Medical device flushing systems and methods

ABSTRACT

A distal end portion of an elongate shaft member of a catheter may be inserted into a liquid within a vessel. While the distal end portion of the elongate shaft member is inserted in the liquid in the vessel, a manipulable portion of the catheter may be manipulated within the liquid to remove an undesired fluid therefrom. The liquid may be pressurized to cause the liquid to flow into a lumen of the elongate shaft member from a distal end of the elongate shaft member at least toward a proximal end of the elongate shaft member to facilitate flushing of the undesired fluid from the lumen. The distal end portion of the elongate shaft member of the catheter may be inserted into the liquid within the vessel while at least the elongate shaft member is in a substantially horizontal orientation.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/986,188, filed May 22, 2018, which is a continuation of InternationalApplication No. PCT/CA2016/000298, filed on Dec. 1, 2016, which claimsthe benefit of U.S. Provisional Application No. 62/281,283, filed Jan.21, 2016, the entire disclosure of each of these applications is herebyincorporated herein by reference.

TECHNICAL FIELD

Aspects of this disclosure generally are related to apparatus andmethods for flushing a medical system, such as a catheter system, of anundesired fluid. In some embodiments, the catheter system includes acontrollable manipulable portion.

BACKGROUND

Cardiac surgery was initially undertaken using highly invasive openprocedures. A sternotomy, which is a type of incision in the center ofthe chest that separates the sternum, was typically employed to allowaccess to the heart. In the past several decades, more and more cardiacoperations are performed using intravascular or percutaneous techniques,where access to inner organs or other tissue is gained via a catheter.

Intravascular or percutaneous surgeries benefit patients by reducingsurgery risk, complications and recovery time. However, the use ofintravascular or percutaneous technologies also raises some particularchallenges. Medical devices used in intravascular or percutaneoussurgery need to be deployed via catheter systems which significantlyincrease the complexity of the device structure. As well, doctors do nothave direct visual contact with the medical devices once the devices arepositioned within the body.

One example of where intravascular or percutaneous medical techniqueshave been employed is in the treatment of a heart disorder called atrialfibrillation. Atrial fibrillation is a disorder in which spuriouselectrical signals cause an irregular heartbeat. Atrial fibrillation hasbeen treated with open heart methods using a technique known as the“Cox-Maze procedure”. During various procedures, health care providerscreate specific patterns of lesions in the left or right atria to blockvarious paths taken by the spurious electrical signals. Such lesionswere originally created using incisions, but are now typically createdby ablating the tissue with various techniques including radio-frequency(RF) energy, microwave energy, laser energy, and cryogenic techniques.The procedure is performed with a high success rate under the directvision that is provided in open procedures, but is relatively complex toperform intravascularly or percutaneously because of the difficulty increating the lesions in the correct locations.

Preparation of catheter device systems for subsequent delivery through abodily opening leading to a bodily cavity (e.g., as required by somepercutaneous or intravascular procedures) may require that variousfluids (e.g., air) be purged or otherwise removed from portions of thesystems prior to insertion into the body. Failure to do so may allow fora transfer of at least some of the fluids to within the body which mayin turn result in various undesired outcomes (e.g., the formation ofvarious air embolisms). Various catheter device systems employ variousfeatures that can act as fluid traps from which undesired fluid can bedifficult to remove therefrom. For example, various lumens comprised byvarious catheter device systems may act as fluid traps. FIG. 7A is aschematic that shows at least part of a conventional catheter systemthat includes a catheter sheath 812 including a lumen that provides apassageway for a catheter member (not shown) delivered through a bodilyopening during a medical procedure. A dilator 800 is typically insertedthrough the lumen of the catheter sheath 812 from the proximal end 812 aof the catheter sheath 812 to the distal end 812 b of the cathetersheath 812. A point-like end 813 of the dilator 800 typically protrudesfrom the distal end 812 b of the catheter shaft 812 when the dilator 800is operably inserted into the lumen of the catheter sheath 812. Thedilator 800/catheter sheath 812 assembly are then advanced through thebodily opening with the protruding point-like end 813 of the dilator 800dilating or enlarging various parts of the bodily opening to facilitatethe advancement of the assembly through the bodily opening. Once theassembly has been successfully delivered through the bodily opening to adesired location within the body, the dilator 800 is pulled out of thecatheter sheath 812 leaving the catheter sheath 812 behind in the bodilyopening. A catheter or other medical instrument is then advanced throughthe lumen of the catheter sheath 812 to the desired location within thebody.

It is noted that undesired fluid (e.g., air) may be present, forexample, in the lumen of the catheter sheath 812, at least before orafter the insertion of the dilator 800 into the lumen. This undesiredfluid requires removal (e.g., to avoid introducing the undesired fluidin the body) prior to advancement of the assembly of the dilator800/catheter sheath 812 through the bodily opening. Conventionalcatheter systems attempt to flush the undesired fluid by introducing aliquid, such as saline, into the region of the lumen of the cathetersheath 812 to flush the lumen of the undesired fluid. The introductionof liquid into the lumen of the catheter sheath 812 to remove theundesired fluid therefrom may occur at least before the insertion of thedilator 800 into the lumen or after the insertion of the dilator 800into the lumen. It is noted that even if the lumen of the cathetersheath 812 is filled with the liquid, the introduction of the dilatorinto the lumen may introduce undesired fluid into the lumen of thecatheter sheath 812 prior to advancement of the assembly though thebodily opening, thereby further complicating the flushing procedure.

FIG. 7B shows a typical flushing procedure employed by conventionalcatheter systems. A source 802 of liquid 804 (e.g., saline) is fluidlyconnected to the catheter sheath 812 at a location at least proximatethe proximal end 812 a to attempt to flush a region of the lumen betweenthe dilator 800 and the catheter sheath 812. It is noted thatconventional flushing systems flush proximally (near proximal end 812 a)toward distally (toward distal end 812 b) because the supply connector812 c for the flushing liquid is provided proximally and not distally onthe catheter member. In conventional flushing systems, a distal supplyconnector (e.g., a distal connector located proximate the distal end 812b of catheter sheath 812 rather than proximate proximal end 812 a) wouldinterfere with the introduction of the catheter member into the bodilyopening and is therefore not employed.

It is noted that the fit between the dilator 800 and catheter sheath 812is typically relatively snug and this fit can act as a fluid restrictionthat may entrap the undesired fluid (e.g., air) when the dilator 800 isadvanced into the lumen of the catheter sheath 812. Typically, theassembly of the catheter sheath 812 and dilator 800 is held inclined orvertically (i.e., distal end 812 b up) to try to promote conveying anybubbles of the undesired fluid (i.e., which is typically less dense thanthe liquid) upwards. This orientation may become cumbersome especiallywhen it is required to perform this procedure in a sterile field.Further, it is noted that the flow rate of the flushing liquid 804 isreduced by the supply connector 812 c and the supply line 803 couplingthe supply connector 812 c to the source 802 of liquid 804 (e.g., thesupply lumens in the supply connector 812 c and the supply line 803typically have smaller cross-sectional areas (i.e., typically driven bythe standardized sizes of various components such as Luer Lockconnectors) than the cross-sectional area of the lumen of the cathetersheath 812 into which the dilator 800 is advanced). Reduced flow ratesfor the flushing liquid 804 may be insufficient to completely flushbubbles of undesired fluid from the lumen of the catheter sheath 812.This condition may be especially prevalent when lumens having relativelarge cross-sectional areas (e.g., in comparison to the cross-sectionalareas of the supply lumens in the supply connector 812 c and the supplyline 803 coupling the supply connector 812 c to the source of liquid804) thereby increasing the amount of surface area to which the bubblesof the undesired fluid may cling. In some cases, relatively low flowrates of the flushing liquid 804 may merely push many of the clingingsmaller bubbles of the undesired fluid together to form larger bubblesof the undesired fluid, which, if subsequently released into thepatient, may lead to the formation of even potentially more harmfulemboli (i.e., than emboli formed by the smaller bubbles) in someprocedures.

Even various materials that may be employed by various catheter devicesystems may make it difficult to remove undesired fluid. For example,polytetrafluoroethylene (PTFE) is typically employed by various catheterdevice systems because of its relatively low friction characteristics.However, polytetrafluoroethylene is an example of a material thatessentially is hydrophobic in nature, and, thus, can restrict removal offluid bubbles on a surface thereof when a water-based liquid (e.g.,saline) is employed to flush or otherwise remove the fluid bubbles. Thatis, the flow of the flushing liquid may be insufficient to flush bubblesaccumulated on a surface of the lumen, especially when that surface hashydrophobic characteristics which tend to repel the liquid, therebyreducing the flushing ability of the liquid.

It is noted that a catheter member or medical instrument that issubsequently advanced into the lumen of the catheter sheath 812 may alsoinclude various internal lumens that require flushing of undesiredfluids. Additionally or alternatively, various channels produced byvarious elements of the catheter member or medical instrument (e.g.,converging elongated elements of basket-type catheter devices) may actas fluid traps.

Accordingly, a need in the art exists for systems and methods havingimproved capabilities for the removal of undesired fluid from medicaldevice systems, such as catheter device systems.

SUMMARY

At least the above-discussed need is addressed and technical solutionsare achieved by various embodiments of the present invention. In someembodiments, a flushing kit for flushing a catheter is provided. Thecatheter includes an elongate shaft member that includes a proximal end,a distal end, a length from the proximal end to the distal end, and atleast a first lumen extending between the proximal end and the distalend. The first lumen includes a first end located at least proximate theproximal end of the elongate shaft member and a second end located atleast proximate the distal end of the elongate shaft member. In variousembodiments, the distal end of the elongate member is arranged to bedeliverable ahead of the proximal end of the elongate shaft memberthrough a bodily opening leading to a bodily cavity, the length of theelongate shaft member sufficient to position the proximal end outside abody including the bodily cavity during a state in which the distal endis positioned in the bodily cavity. According to some embodiments, theflushing kit may be summarized as including a vessel including aninterior cavity and a first port in fluid communication with theinterior cavity. A first portion of the interior cavity is sized toreceive at least a quantity of liquid sufficient to flush the firstlumen of the elongate shaft member of a fluid other than the liquid. Thefirst port is sized to removably receive a distal end portion of theelongate shaft member, the distal end portion of the elongate shaftmember including the distal end of the elongate shaft member and thesecond end of the first lumen. According to various embodiments, thevessel includes a size too large for delivery through the bodily openingleading to the bodily cavity at least in a state in which the interiorcavity is void of the liquid. According to various embodiments, theflushing kit includes a seal arranged to selectively seal an exteriorsurface of a first part of the distal end portion of the elongate shaftmember to a portion of the vessel in a state in which at least a secondpart of the distal end portion of the elongate shaft member includingthe distal end of the elongate shaft member and the second end of thefirst lumen is positioned, via the first port, in the interior cavity ata location suitable to supply at least part of the liquid into thesecond end of the first lumen to flush the first lumen of the fluidother than the liquid in a direction through the first lumen extendingfrom the second end of the first lumen toward the first end of the firstlumen.

In some embodiments, the vessel may include a second port in fluidcommunication with the interior cavity, the second port arranged tofluidly communicate with a source of particular fluid other than theliquid and provide the particular fluid into a second portion of theinterior cavity to pressurize the liquid in the first portion of theinterior cavity. In various embodiments, the first port and the secondport are different ports. In some embodiments, the second port may bearranged to avoid receiving the distal end portion of the elongate shaftmember when the distal end portion of the elongate shaft member isreceived in the first port. In some embodiments, the second port may bepositioned to permit a flow of the particular fluid from the secondportion of the interior cavity through the second port whileconcurrently preventing a flow of the liquid from the first portion ofthe interior cavity through the second port at least during a state inwhich the liquid in the first portion of the interior cavity undergoes areduction in pressure. In some embodiments, the vessel may bepositionable to permit a flow of the particular fluid from the secondportion of the interior cavity through the second port whileconcurrently preventing a flow of the liquid from the first portion ofthe interior cavity through the second port at least during a state inwhich the liquid in the first portion of the interior cavity undergoes areduction in pressure.

In some embodiments, the vessel may include a conduit member arranged tofluidly communicate with the source of particular fluid, the conduitmember including a first conduit end, a second conduit end and a secondlumen extending between the first conduit end and the second conduitend. According to some embodiments, the first conduit end is arranged toreceive the particular fluid from the source of particular fluid, andthe second lumen is arranged to convey a flow of the particular fluidtoward the second conduit end, the second conduit end being arranged toprovide the particular fluid into the second portion of the interiorcavity. In some embodiments, the second port may be provided by thesecond conduit end. In some embodiments, the conduit member may bearranged to locate the second conduit end at a location in the interiorcavity away from the liquid in the first portion of the interior cavity.At least part of the conduit member may extend across at least part ofthe first portion of the interior cavity according to some embodiments.

In some embodiments, the conduit member may be arranged to locate thesecond conduit end in the second portion of the interior cavity. In someembodiments, the second lumen may be arranged to avoid receiving thedistal end portion of the elongate shaft member when the distal endportion of the elongate shaft member is received in the first port. Insome embodiments, the flushing kit may include a first valve coupledbetween the first conduit end of the conduit member and the source ofparticular fluid. According to some embodiments, the first valve may beselectively operable in a first state in which the particular fluid isallowed to flow via the conduit member from the source of particularfluid to the second portion of the interior cavity, and the first valvemay be selectively operable in a second state in which the particularfluid is restricted from flowing via the conduit member from the sourceof particular fluid to the second portion of the interior cavity. Insome embodiments, the first valve may be selectively operable in a thirdstate in which the particular fluid is restricted from flowing via theconduit member from the source of particular fluid to the second portionof the interior cavity and the particular fluid is allowed to flow viathe conduit from the second portion of the interior cavity to aparticular location located away from the source of particular fluid,the particular location not located in the interior cavity and notlocated in the elongate shaft member. In some embodiments, the flushingkit may include a check valve operatively coupled between the source ofparticular fluid and the first valve to restrict at least a flow of theparticular fluid from the first valve toward the source of particularfluid.

In some embodiments, the vessel may include a second port in fluidcommunication with the interior cavity, the second port configured tofluidly communicate with a particular fluid in a second portion of theinterior cavity, the particular fluid being other than the liquid. Insome embodiments, the first port and the second port are differentports. In some embodiments, the second port may be arranged to avoidreceiving the distal end portion of the elongate shaft member when thedistal end portion of the elongate shaft member is received in the firstport. In some embodiments, the second port may be positioned to permit aflow of the particular fluid through the second port while concurrentlypreventing a flow of the liquid through the second port. In someembodiments, the vessel may be positionable to permit a flow of theparticular fluid through the second port while concurrently preventing aflow of the liquid through the second port. In some embodiments, thevessel may include a wall portion between the first portion of theinterior cavity and second portion of the interior cavity, at least partof the wall portion moveable to exert pressure on the liquid in thefirst portion of the interior cavity when the particular fluid isreceived in the second portion of the interior cavity.

In some embodiments, the vessel may include a conduit member arranged tofluidly communicate with the source of particular fluid, the conduitmember including a first conduit end, a second conduit end and a secondlumen extending between the first conduit end and the second conduitend. According to some embodiments, the first conduit end is arranged toreceive the particular fluid from the source of particular fluid and thesecond lumen is arranged to convey a flow of the particular fluid towardthe second conduit end, the second conduit end being arranged to providethe particular fluid into the second portion of the interior cavity. Insome embodiments, the second port may be provided by the second conduitend. In some embodiments, the conduit member may be arranged to locatethe second conduit end at a location in the interior cavity away fromthe liquid in the first portion of the interior cavity. In someembodiments, at least part of the conduit member may extend across atleast part of the first portion of the interior cavity.

In some embodiments, the conduit member may be arranged to locate thesecond conduit end in the second portion of the interior cavity. In someembodiments, the second lumen may be arranged to avoid receiving thedistal end portion of the elongate shaft member when the distal endportion of the elongate shaft member is received in the first port. Insome embodiments, the flushing kit may include a first three-way valveoperatively coupled between the second port and the source of particularfluid. In some embodiments, the flushing kit may include a check valveoperatively coupled between the source of particular fluid and the firstthree-way valve to restrict at least a flow of the particular fluid fromthe first three-way valve toward the source of particular fluid. In someembodiments, the flushing kit may include a second three-way valveoperatively coupled between the check valve and the source of particularfluid.

In some embodiments, a second portion of the interior cavity may besized to receive at least a quantity of particular fluid other than theliquid, the quantity of particular fluid being sufficient to exertpressure on the liquid in the first portion of the interior cavity, thepressure sufficient to cause movement of at least some of the liquid inthe first portion of the interior cavity into the second end of thefirst lumen and flush the first lumen of the fluid other than the liquidin the direction through the first lumen extending from the second endof the first lumen toward the first end of the first lumen.

In some embodiments, the vessel may be sized too large to bepercutaneously delivered through the bodily opening leading to thebodily cavity at least in the state in which the first portion of theinterior cavity is void of the liquid.

In some embodiments, the vessel may include a removable cap, the capremovable to provide access to the interior cavity. In some embodiments,the first port may be provided in the cap. In some embodiments, a secondportion of the interior cavity may be sized to contain at least aquantity of particular fluid other than the liquid concurrently with theliquid received in the first portion of the interior cavity. In someembodiments, the vessel may include a second port in fluid communicationwith the interior cavity, the second port positioned to permit a flow ofthe particular fluid through the second port while concurrentlypreventing a flow of the liquid through the second port. In variousembodiments, the first port and the second port are different portsprovided in the cap.

In some embodiments, the vessel may include a size too large to fit inthe bodily cavity at least in the state in which the first portion ofthe interior cavity is void of the liquid. In some embodiments, theexterior surface of the first part of the distal end portion of theelongate shaft member may be a cylindrical surface. In some embodiments,the portion of the vessel may be an engagement surface of the seal. Insome embodiments, the engagement surface of the seal is aradially-inward-facing surface. In some embodiments, the engagementsurface is a circumferential surface.

In some embodiments, the catheter includes a manipulable portionphysically coupled to the distal end portion of the elongate shaftmember, the manipulable portion being selectively moveable between adelivery configuration and a deployed configuration, a size of themanipulable portion in the deployed configuration being larger than acorresponding size of the manipulable portion in the deployedconfiguration. In some embodiments, the first port is sized to permitdelivery of the manipulable portion through the first port when themanipulable portion is in the delivery configuration. In someembodiments, the first port is sized to restrict delivery of themanipulable portion through the first port when the manipulable portionis in the deployed configuration. In some embodiments, a volume of thefirst portion of the interior cavity may be greater than a volumeencompassed by the manipulable portion when the manipulable portion isin the deployed configuration.

In some embodiments, the catheter includes a manipulable portionphysically coupled to the distal end portion of the elongate shaftmember, the manipulable portion being selectively moveable between adelivery configuration in which the manipulable portion is sized topermit delivery of the manipulable portion through the bodily openingleading to the bodily cavity and a deployed configuration in which themanipulable portion is sized too large to permit delivery of themanipulable portion through the bodily opening leading to the bodilycavity. According to some embodiments, a volume of the first portion ofthe interior cavity may be greater than a volume encompassed by themanipulable portion when the manipulable portion is in the deployedconfiguration.

Various flushing kits may include combinations and subset of thosesummarized above.

In some embodiments, a catheter is provided, the catheter including anelongate shaft member that includes a proximal end, a distal end, alength from the proximal end to the distal end, and at least a firstlumen extending between the proximal end and the distal end. The firstlumen includes a first end located at least proximate the proximal endof the elongate shaft member and a second end located at least proximatethe distal end of the elongate shaft member.

According to various embodiments, the distal end of the elongate shaftmember is arranged to be deliverable ahead of the proximal end of theelongate shaft member through a bodily opening leading to a bodilycavity. According to various embodiments, the length of the elongateshaft member is sufficient to position the proximal end outside a bodythat includes the bodily cavity during a state in which the distal endis positioned in the bodily cavity. According to various embodiments, amethod for flushing the catheter may be summarized as includingproviding a quantity of liquid into at least a first portion of aninterior cavity of a vessel. According to various embodiments, themethod includes inserting at least part of a distal end portion of theelongate shaft member including the distal end of the elongate shaftmember and the second end of the first lumen into the interior cavityvia a first port provided by the vessel, the second end of the firstlumen in fluid communication with the liquid provided in the firstportion of the interior cavity. According to various embodiments, themethod includes establishing a flow of at least some of the liquid inthe first portion of the interior cavity through the first lumen fromthe second end of the first lumen toward the first end of the firstlumen to flush a fluid other than the liquid from the first lumen.

In some embodiments, the method may include removing the at least partof the distal end portion of the elongate shaft member from the interiorcavity prior to a delivery of at least part of the catheter through thebodily opening leading to the bodily cavity. In some embodiments, themethod may include removing the at least part of the distal end portionof the elongate shaft member from the interior cavity prior to adelivery of at least the distal end portion of the elongate shaft memberthrough the bodily opening leading to the bodily cavity. In someembodiments, the vessel includes a size too large for delivery of thevessel through the bodily opening leading to the bodily cavity at leastin a state in which the first portion of the interior cavity is void ofthe liquid.

In some embodiments, the liquid in at least the first portion of theinterior cavity is pressurized. In some embodiments, the method mayinclude pressurizing the liquid in at least the first portion of theinterior cavity after the liquid is provided in the first portion of theinterior cavity. In some embodiments, the method may includepressurizing the liquid in at least the first portion of the interiorcavity of the chamber to establish the flow of at least some of theliquid in the first portion of the interior cavity through the firstlumen from the second end of the first lumen toward the first end of thefirst lumen to flush the fluid other than the liquid from the firstlumen.

In some embodiments, the method may include providing a particular fluidinto a second portion of the interior cavity to pressurize the liquidprovided in the first portion of the interior cavity. In someembodiments, the particular fluid is different than the liquid.

In some embodiments, the method may include providing a quantity ofparticular fluid other than the liquid into a second portion of theinterior cavity while at least some of the liquid is in the firstportion of the interior cavity. In some embodiments, the vessel mayinclude a second port in fluid communication with the interior cavity,the second port other than the first port, and at least some of thequantity of particular fluid may be provided into the second portion ofthe interior cavity at least through the second port. In someembodiments, the second port may be arranged to prevent any reception ofthe distal end portion of the elongate shaft member when the distal endportion of the elongate shaft member is inserted into the interiorcavity via the first port. In some embodiments, the second port ispositionable to permit a flow of the particular fluid through the secondport while concurrently preventing a flow of the liquid through thesecond port.

In some embodiments, the method may include providing a quantity ofparticular fluid other than the liquid into a second portion of theinterior cavity, the quantity of particular fluid being sufficient toexert pressure on the liquid in the first portion of the interiorcavity, the pressure sufficient to cause the establishing the flow ofthe at least some of the liquid in the first portion of the interiorcavity through the first lumen from the second end of the first lumentoward the first end of the first lumen to flush the fluid other thanthe liquid from the first lumen. In some embodiments, the method mayinclude providing the quantity of particular fluid other than the liquidinto the second portion of the interior cavity after the quantity ofliquid has been provided into at least the first portion of the interiorcavity.

In some embodiments, the method may include providing a quantity ofparticular fluid other than the liquid into a second portion of theinterior cavity after the quantity of liquid has been provided into atleast the first portion of the interior cavity.

In some embodiments, the method may include providing a quantity ofparticular fluid other than the liquid into a second portion of theinterior cavity while at least some of the liquid is in the firstportion of the interior cavity. In some embodiments, the vessel mayinclude a second port in fluid communication with the interior cavity,the second port other than the first port, and at least some of thequantity of particular fluid being provided into the second portion ofthe interior cavity at least through the second port. In someembodiments, the vessel may include a wall portion, and the methodincludes moving at least part of the wall portion to exert pressure onthe liquid in the first portion of the interior cavity, the pressuresufficient to cause the establishing the flow of the at least some ofthe liquid in the first portion of the interior cavity through the firstlumen from the second end of the first lumen toward the first end of thefirst lumen to flush the fluid other than the liquid from the firstlumen. In some embodiments, the wall portion may be provided between thefirst portion of the interior cavity and the second portion of theinterior cavity.

In some embodiments, the method may include providing a quantity ofparticular fluid other than the liquid into a second portion of theinterior cavity while at least some of the liquid is in the firstportion of the interior cavity. In some embodiments, the vessel mayinclude a conduit member that includes a first conduit end, a secondconduit end, and a second lumen extending between the first conduit endand the second conduit end. According to some embodiments, the methodmay include conveying a flow of the particular fluid though the secondlumen toward the second conduit end, the second conduit end beingarranged to provide at least some of the quantity of particular fluidinto the second portion of the interior cavity. In some embodiments, theconduit member may be arranged to locate the second conduit end at alocation in the interior cavity away from the liquid provided in thefirst portion of the interior cavity. In some embodiments, at least partof the conduit member may extend across at least part of the firstportion of the interior cavity. In some embodiments, the conduit membermay be arranged to locate the second conduit end in the second portionof the interior cavity. In some embodiments, the second lumen may bearranged to prevent any reception of the distal end portion of theelongate shaft member when the distal end portion of the elongate shaftmember is inserted into the interior cavity via the first port. In someembodiments, the quantity of particular fluid is sufficient to exertpressure on the liquid, and the pressure sufficient to cause theestablishing the flow of the at least some of the liquid in the firstportion of the interior cavity through the first lumen from the secondend of the first lumen toward the first end of the first lumen to flushthe fluid other than the liquid from the first lumen.

In some embodiments, the method may include providing a quantity ofparticular fluid other than the liquid into a second portion of theinterior cavity while at least some of the liquid is in the firstportion of the interior cavity. In some embodiments, the vessel mayinclude a second port in fluid communication with the interior cavity,the second port other than the first port, and at least some of thequantity of particular fluid being provided into the second portion ofthe interior cavity at least through the second port. In someembodiments, the vessel may include a removable cap, the cap removableto provide access to the interior cavity and wherein both the first portand the second port are provided in the cap.

In some embodiments, the vessel may include a removable cap, the capremovable to provide access to the interior cavity and wherein the firstport is provided in the cap.

In some embodiments, the method may include manipulating a seal memberto seal an exterior surface of the distal end portion of the elongateshaft member to at least part of the vessel, and subsequently,manipulating the seal member to unseal the exterior surface of thedistal end portion of the elongate shaft member from the at least partof the vessel at least prior to a delivery of at least the distal endportion of the elongate shaft member through the bodily opening leadingto the bodily cavity. In some embodiments, the method may includepressurizing the liquid in the first portion of the interior cavityafter the manipulating the seal member to seal an exterior surface ofthe distal end portion of the elongate shaft member to the at least partof the vessel but before the manipulating the seal member to unseal theexterior surface of the distal end portion of the elongate shaft memberfrom the at least part of the vessel.

In some embodiments, the catheter comprises a manipulable portionphysically coupled to the distal end portion of the elongate shaftmember, the manipulable portion selectively moveable from an unexpandedconfiguration in which the manipulable portion is sized for deliverythrough the first port and an expanded configuration in which themanipulable portion is sized too large for delivery through the firstport, and wherein the method comprises delivering the manipulableportion in the unexpanded configuration via the first port into thefirst portion of the interior cavity. In some embodiments, the methodmay include moving the manipulable portion from the unexpandedconfiguration to the expanded configuration in the first portion of theinterior cavity. In some embodiments, the method may include repeatedlymoving the manipulable portion, when the manipulable portion is in theexpanded configuration in the first portion of the interior cavity toagitate the liquid in the first portion of the interior cavity. In someembodiments, the method may include moving the manipulable portion fromthe unexpanded configuration to the expanded configuration while themanipulable portion is wetted by the liquid provided in the firstportion of the interior cavity.

In some embodiments, the method may include pressurizing the liquid inat least the first portion of the interior cavity after the liquid isprovided in the first portion of the interior cavity to prevent fluidflow from the first lumen into the interior cavity.

In some embodiments, the method may include providing a particular fluidinto a second portion of the interior cavity to pressurize the liquidprovided in the first portion of the interior cavity. In someembodiments, the providing the particular fluid into the second portionof the interior cavity to pressurize the liquid in the first portion ofthe interior cavity may include providing the particular fluid into thesecond portion of the interior cavity via a second port provided by thevessel. According to some embodiments, the method may include removingat least some of the particular fluid from the second portion of theinterior cavity to depressurize the liquid in the first portion of theinterior cavity, the at least some of the particular fluid removed fromthe second portion of the interior cavity via a third port provided bythe vessel, each of the second and the third port being other than thefirst port. In some embodiments, the third port may be provided by thesecond port.

Various methods can include combinations and subsets of those summarizedabove.

Various embodiments of the present invention may include systems,devices, or machines that are or include combinations or subsets of anyor all of the systems, devices, or machines and associated featuresthereof described herein.

Further, all or part of any or all of the systems, devices, or machinesdiscussed herein or combinations or subcombinations thereof mayimplement or execute all or part of any or all of the methods discussedherein or combinations or subcombinations thereof. Further, any or allof the methods and associated features thereof discussed herein may beimplemented or executed by all or part of a device system, apparatus, ormachine, such as all or a part of any of the systems, apparatuses, ormachines described herein or a combination or subcombination thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

It is to be understood that the attached drawings are for purposes ofillustrating aspects of various embodiments and may include elementsthat are not to scale.

FIG. 1 is a cutaway diagram of a heart showing a transducer-based devicepercutaneously delivered to a left atrium of the heart, according tosome example embodiments.

FIG. 2A is a partially schematic representation of a catheter system,according to some example embodiments, the system, which may also bereferred to as a medical system, including a data processing devicesystem, an input-output device system, a processor-accessible memorydevice system, and a manipulable portion shown in a delivery orunexpanded configuration.

FIG. 2B is the catheter system of FIG. 2A with the manipulable portionshown in a deployed or expanded configuration, according to some exampleembodiments.

FIG. 3 is a schematic representation of a transducer-based device thatincludes a flexible circuit structure, according to some exampleembodiments.

FIG. 4A is a perspective representation of a catheter system, accordingto some example embodiments.

FIG. 4B is a perspective representation of a portion of the cathetersystem of FIG. 4A, according to some example embodiments.

FIG. 5A illustrates a flushing kit including a cap, according to someexample embodiments.

FIG. 5B is a perspective representation of the cap of FIG. 5A, accordingto some example embodiments.

FIG. 5C is an exploded view of the cap of FIG. 5B, according to someexample embodiments.

FIG. 5D is a cutaway diagram of the cap of FIG. 5B, according to someexample embodiments.

FIG. 5E illustrates a portion of the flushing kit of FIG. 5A in aconfiguration to flush a catheter system, such as a portion of thecatheter system of FIG. 4A, according to some example embodiments.

FIG. 5F illustrates the flushing kit of FIG. 5A in a configuration toflush a catheter system, such as a portion of the catheter system ofFIG. 4A, according to some example embodiments.

FIG. 5G illustrates a portion of the flushing kit of FIG. 5A in aconfiguration to flush a catheter system, such as a portion of thecatheter system of FIG. 4A, according to some example embodiments.

FIG. 6A illustrates a catheter system in a flushing configuration,according to some example embodiments.

FIG. 6B illustrates removal of undesired fluid from a manipulableportion of a catheter system, according to some example embodiments.

FIG. 7A is a schematic that shows at least part of a conventionalcatheter system.

FIG. 7B illustrates a typical flushing procedure employed byconventional catheter systems.

FIG. 8A is a block diagram representing a method for flushing at least alumen of a catheter system, according to some example embodiments.

FIG. 8B illustrates an exploded view of a portion of the method of FIG.8A, according to some example embodiments.

FIG. 8C illustrates an exploded view of a method block or element ofFIG. 8B, according to some example embodiments.

FIG. 8D is a block diagram of a method for providing a quantity ofparticular fluid into a portion of an interior cavity of a vessel of theflushing kit, according to some example embodiments.

DETAILED DESCRIPTION

Various embodiments of the present invention address the above-discussedneed and provide technical solutions in the art with inventive medicaldevice flushing systems and methods. In some embodiments, such systemsand methods include inserting a distal end portion of an elongate shaftmember of a catheter into liquid within a vessel. In some embodiments,the liquid is pressurized, which causes the liquid to flow into a lumenof the elongate shaft member from the distal end of the elongate shaftmember at least toward the proximal end of the elongate shaft member toflush undesirable fluid (e.g., air) from the lumen, in contrast toconventional proximal-end-to-distal-end flushing schemes.Distal-end-toward-proximal-end flushing can be more beneficial thanconventional proximal-end-to-distal-end flushing schemes, at leastbecause it becomes possible to impart higher flow rates in the flushingliquid thereby increasing the flushing efficacy according to someembodiments. In some embodiments, while the distal end portion of theelongate shaft member is inserted in the liquid in the vessel, amanipulable portion of the catheter system is manipulated (e.g.,expanded and contracted or otherwise manipulated) within the liquid toflush or otherwise remove undesired fluid therefrom, which is anotherbenefit of distal-end-toward-proximal-end flushing, as it allows themanipulable portion to be cleansed of undesired fluid along with thelumen of the elongate member. In some embodiments, the distal endportion of the elongate shaft member of the catheter is inserted intothe liquid within the vessel while at least the elongate shaft member isin a substantially horizontal orientation, which can be more beneficialthan conventional vertical flushing orientations at least because thehorizontal flushing arrangement is easier to physically handle . Itshould be noted that the invention is not limited to these or any otherexamples provided herein, which are referred to for purposes ofillustration only.

In this regard, in the descriptions herein, certain specific details areset forth in order to provide a thorough understanding of variousembodiments of the invention. However, one skilled in the art willunderstand that the invention may be practiced at a more general levelwithout one or more of these details. In other instances, well-knownstructures have not been shown or described in detail to avoidunnecessarily obscuring descriptions of various embodiments of theinvention.

Any reference throughout this specification to “one embodiment”, “anembodiment”, “an example embodiment”, “an illustrated embodiment”, “aparticular embodiment”, and the like means that a particular feature,structure or characteristic described in connection with the embodimentis included in at least one embodiment. Thus, any appearance of thephrase “in one embodiment”, “in an embodiment”, “in an exampleembodiment”, “in this illustrated embodiment”, “in this particularembodiment”, or the like in this specification is not necessarily allreferring to one embodiment or a same embodiment. Furthermore, theparticular features, structures or characteristics of differentembodiments may be combined in any suitable manner to form one or moreother embodiments.

Unless otherwise explicitly noted or required by context, the word “or”is used in this disclosure in a non-exclusive sense. In addition, unlessotherwise explicitly noted or required by context, the word “set” isintended to mean one or more. For example, the phrase, “a set ofobjects” means one or more of the objects. In addition, unless otherwiseexplicitly noted or required by context, the word “subset” is intendedto mean a set having the same or fewer elements of those present in thesubset's parent or superset.

Further, the phrase “at least” is or may be used herein at times merelyto emphasize the possibility that other elements may exist besides thoseexplicitly listed. However, unless otherwise explicitly noted (such asby the use of the term “only”) or required by context, non-usage hereinof the phrase “at least” nonetheless includes the possibility that otherelements may exist besides those explicitly listed. For example, thephrase ‘based at least on A’ includes A as well as the possibility ofone or more other additional elements besides A. In the same manner, thephrase ‘based on A’ includes A, as well as the possibility of one ormore other additional elements besides A. However, the phrase ‘basedonly on A’ includes only A. Similarly, the phrase ‘configured at leastto A’ includes a configuration to perform A, as well as the possibilityof one or more other additional actions besides A. In the same manner,the phrase ‘configured to A’ includes a configuration to perform A, aswell as the possibility of one or more other additional actions besidesA. However, the phrase ‘configured only to A’ means a configuration toperform only A.

The word “device”, the word “machine”, and the phrase “device system”all are intended to include one or more physical devices or sub-devices(e.g., pieces of equipment) that interact to perform one or morefunctions, regardless of whether such devices or sub-devices are locatedwithin a same housing or different housings. However, it may beexplicitly specified according to various embodiments that a device ormachine or device system resides entirely within a same housing toexclude embodiments where the respective device, machine, or devicesystem resides across different housings. The word “device” mayequivalently be referred to as a “device system” in some embodiments.

Further, the phrase “in response to” may be used in this disclosure. Forexample, this phrase may be used in the following context, where anevent A occurs in response to the occurrence of an event B. In thisregard, such phrase includes, for example, that at least the occurrenceof the event B causes or triggers the event A.

In some embodiments, the term “adjacent”, the term “proximate”, and thelike refer at least to a sufficient closeness between the objectsdefined as adjacent, proximate, or the like, to allow the objects tointeract in a designated way. For example, if object A performs anaction on an adjacent or proximate object B, objects A and B would haveat least a sufficient closeness to allow object A to perform the actionon object B. In this regard, some actions may require contact betweenthe associated objects, such that if object A performs such an action onan adjacent or proximate object B, objects A and B would be in contact,for example, in some instances or embodiments where object A needs to bein contact with object B to successfully perform the action. In someembodiments, the term “adjacent”, the term “proximate”, and the likeadditionally or alternatively refers to objects that do not have anothersubstantially similar object between them. For example, object A andobject B could be considered adjacent or proximate if they contact eachother (and, thus, it could be considered that no other object is betweenthem), or if they do not contact each other but no other object that issubstantially similar to object A, object B, or both objects A and B,depending on the embodiment, is between them. In some embodiments, theterm “adjacent”, the term “proximate”, and the like additionally oralternatively refers to at least a sufficient closeness between theobjects defined as adjacent, proximate, and the like, the sufficientcloseness being within a range that does not place any one or more ofthe objects into a different or dissimilar region, or does not change anintended function of any one or more of the objects or of anencompassing object that includes a set of the objects. Differentembodiments of the present invention adopt different ones orcombinations of the above definitions. Of course, however, the term“adjacent”, the term “proximate”, and the like are not limited to any ofthe above example definitions, according to some embodiments. Inaddition, the term “adjacent” and the term “proximate” do not have thesame definition, according to some embodiments.

The word “ablation” as used in this disclosure should be understood toinclude, for example, any disruption to certain properties of tissue.Most commonly, the disruption is to the electrical conductivity and isachieved by heating, which can be generated with resistive orradio-frequency (RF) techniques for example. However, any othertechnique for such disruption may be included when the term “ablation”is used, such as mechanical, chemical, electroporation or opticaltechniques.

The word “fluid”, as used in this disclosure, should be understood toinclude, for example, liquid or gas.

The phrase “bodily opening” as used in this disclosure should beunderstood to include, for example, a naturally occurring bodily openingor channel or lumen; a bodily opening or channel or lumen or perforationformed by an instrument or tool using techniques that can include, butare not limited to, mechanical, thermal, electrical, chemical, andexposure or illumination techniques; a bodily opening or channel orlumen formed by trauma to a body; or various combinations of one or moreof the above. Various elements having respective openings, lumens orchannels and positioned within the bodily opening (e.g., a cathetersheath or catheter introducer) may be present in various embodiments.These elements may provide a passageway through a bodily opening forvarious devices employed in various embodiments.

The phrase “bodily cavity” as used in this disclosure should beunderstood to mean a cavity in a body. The bodily cavity may be a cavityprovided in a bodily organ (e.g., an intra-cardiac cavity or chamber ofa heart). The bodily cavity may be provided by a bodily vessel.

The word “tissue” as used in some embodiments in this disclosure shouldbe understood to include, for example, any surface-forming tissue thatis used to form a surface of a body or a surface within a bodily cavity,a surface of an anatomical feature or a surface of a feature associatedwith a bodily opening positioned in fluid communication with the bodilycavity. The tissue can include, for example, part or all of a tissuewall or membrane that defines a surface of the bodily cavity. In thisregard, the tissue can form an interior surface of the cavity thatsurrounds a fluid within the cavity. In the case of cardiacapplications, tissue can include, for example, tissue used to form aninterior surface of an intra-cardiac cavity such as a left atrium orright atrium. In some embodiments, tissue is non-excised tissue. In someembodiments, the word tissue can refer to a tissue having fluidicproperties (e.g., blood).

The term “transducer” as used in this disclosure should be interpretedbroadly as any device capable of distinguishing between fluid andtissue, sensing temperature, creating heat, ablating tissue, measuringelectrical activity of a tissue surface, stimulating tissue, or anycombination thereof. A transducer can convert input energy of one forminto output energy of another form. Without limitation, a transducer caninclude, for example, an electrode that functions as, or as part of, asensing device included in the transducer, an energy delivery deviceincluded in the transducer, or both a sensing device and an energydelivery device included in the transducer. A transducer may beconstructed from several parts, which may be discrete components or maybe integrally formed.

The term “activation” as used in this disclosure should be interpretedbroadly as making active a particular function as related to varioustransducers disclosed in this disclosure. Particular functions caninclude, but are not limited to, tissue ablation, sensingelectrophysiological activity, sensing temperature and sensingelectrical characteristics (e.g., tissue impedance). For example, insome embodiments, activation of a tissue ablation function of aparticular transducer is initiated by causing energy sufficient fortissue ablation from an energy source device system to be delivered tothe particular transducer. Alternatively, in this example, theactivation can be deemed to be initiated when the particular transduceris activated to cause a temperature sufficient for the tissue ablationdue to the energy provided by the energy source device system. Also inthis example, the activation can last for a duration of time concludingwhen the ablation function is no longer active, such as when energysufficient for the tissue ablation is no longer provided to theparticular transducer. Alternatively, in this example, the activationperiod can be deemed to be concluded when the temperature caused by theparticular transducer is below the temperature sufficient for the tissueablation. In some contexts, however, the word “activation” can merelyrefer to the initiation of the activating of a particular function, asopposed to referring to both the initiation of the activating of theparticular function and the subsequent duration in which the particularfunction is active. In these contexts, the phrase or a phrase similar to“activation initiation” may be used. For example, in some embodiments,activation initiation may cause initiation of a transmission of energy(e.g., energy sufficient for tissue ablation) from a particulartransducer or electrode.

The phrase “physically coupled” is intended to include, in someembodiments, a coupling between two objects that involves a couplingbetween the two objects where the two objects physical contact eachother at least in one state of the coupling between the two objects. Thephrases “fixedly coupled”, “permanently coupled”, and the like, areintended to include, in some embodiments, a secure coupling between twoobjects that, in some embodiments, does not involve or include amechanism configured to release the coupling of the two objects. Thephrases “removably coupled”, “detachably coupled”, and the like, areintended to include, in some embodiments, a coupling between two objectsthat, in some embodiments, allows such coupling to be repeatedlydisengaged and re-engaged without damaging the coupling (if a distinctcoupling mechanism exists, e.g., in contrast to an interference fit thatrelies on friction), without damaging either or both of the objects, orwithout damaging the coupling (if a distinct coupling mechanism exists)and without damaging either or both of the objects. The phrase“operatively coupled” is intended to include, for example, a couplingbetween two objects that transmits force, energy, information, or otherinfluence at least from one of the two objects to the other of the twoobjects. An operative coupling does not exclude the possibility of aphysical or fixed coupling in addition to the operative coupling. Unlessotherwise explicitly noted or required by context, for any connection orcoupling, direct or indirect, between components, devices, or otherphysical objects described herein, different embodiments includedifferent ones of the above-described coupling types for suchcomponents, devices, or other physical objects. For example, unlessotherwise explicitly noted or required by context, if a first physicalobject is shown in the figures or described in this text as beingconnected or coupled, directly or indirectly, to a second physicalobject, some embodiments will have the first physical object fixedlycoupled to the second physical object; other embodiments will have thefirst physical object permanently coupled to the second physical object;other embodiments will have the first physical object removably ordetachably coupled to the second physical object; other embodiments willhave the first physical object not fixedly or permanently coupled to thesecond physical object while having the first physical object physicallycoupled to the second physical object; other embodiments will have thefirst physical object not physically coupled or fixedly coupled to thesecond physical object, but will have the first physical objectoperatively coupled to the second physical object; etc.

In some embodiments, the phrases “fluid communication”, “fluidlycommunicate”, “fluidly coupled”, and the like, are intended to include,for example, a port or opening, of a physical object leading to a lumenor other internal cavity, where the port, opening, lumen, or internalcavity leads to body (e.g., a source or drain) of a first fluid, suchthat (a) at least some of the first fluid moves or is able to movethrough (1) the port or opening into the lumen or other internal cavity,(2) the lumen or other internal cavity into the port or opening, or both(a)(1) and (a)(2); (b) at least some of a second fluid moves or is ableto move through (1) the lumen or other internal cavity into the port oropening, (2) the port or opening into the lumen or other internalcavity, or both (b)(1) and (b)(2); or both (a) and (b). In someembodiments, the first fluid and the second fluid are the same. In someembodiments, the first fluid and the second fluid are different.

Various embodiments of catheter systems or catheter device systems aredescribed herein. It should be noted that any catheter system describedherein may also be referred to as a medical system or medical devicesystem. Some of the described devices of such systems are medicaldevices that are percutaneously or intravascularly deployed. Some of thedescribed devices are deployed through a bodily opening that isaccessible without puncturing, cutting or otherwise perforating bodilytissue to create an access to the bodily opening. Some of the describeddevices employ transducer-based devices or device systems. Some of thedescribed devices are moveable between a delivery or unexpandedconfiguration in which a portion of the device is sized, shaped, or bothfor passage through a bodily opening leading to a bodily cavity, and anexpanded or deployed configuration in which the portion of the devicehas a size, shape, or both too large for passage through the bodilyopening leading to the bodily cavity. An example of an expanded ordeployed configuration is when the portion of the catheter system is inits intended-deployed-operational state inside the bodily cavity.Another example of the expanded or deployed configuration is when theportion of the catheter system is being changed from the deliveryconfiguration to the intended-deployed-operational state to a pointwhere the portion of the device now has a size, shape, or both too largefor passage through the bodily opening leading to the bodily cavity. Insome embodiments, at least a portion of at least one of the describeddevices has a dimension or size that is smaller in the delivery orunexpanded configuration than a corresponding dimension or size of theat least a portion of at least one of the described devices in theexpanded or deployed configuration.

In some example embodiments, the catheter system includes transducersthat sense characteristics (e.g., convective cooling, permittivity,force) that distinguish between fluid, such as a fluidic tissue (e.g.,blood), and tissue forming an interior surface of the bodily cavity.Such sensed characteristics can allow a medical device system to map thecavity, for example using positions of openings or ports into and out ofthe cavity to determine a position or orientation (i.e., pose), or bothof the portion of the device in the bodily cavity. In some exampleembodiments, the described devices are capable of ablating tissue in adesired pattern within the bodily cavity. In some example embodiments,the devices are capable of sensing characteristics (e.g.,electrophysiological activity) indicative of whether an ablation hasbeen successful. In some example embodiments, the devices are capable ofproviding stimulation (e.g., electrical stimulation) to tissue withinthe bodily cavity. Electrical stimulation may include pacing.

FIG. 1 shows a portion of a catheter system, according to someembodiments, such portion including a transducer-based device 200, whichmay be at least part of a medical device useful in investigating ortreating a bodily organ, for example, a heart 202, according to someexample embodiments. The transducer-based device 200 may also bereferred to as a manipulable portion, due to its ability to have itssize, shape, or both size and shape altered, according to someembodiments described below. Transducer-based device 200 can bepercutaneously or intravascularly inserted into a portion of the heart202, such as an intra-cardiac cavity like left atrium 204. Thecomponents of the transducer-based device 200 (as well as thetransducer-based device 300, the catheter system 500, and the kit 600,described below) may be sterile.

In the example of FIG. 1, the illustrated portion of the catheter systemalso includes a catheter 206, which may be inserted via the inferiorvena cava 208 and may penetrate through a bodily opening in transatrialseptum 210 from right atrium 212. In other embodiments, other paths maybe taken.

Catheter 206 includes an elongated flexible rod or elongated shaftmember appropriately sized to be delivered percutaneously orintravascularly. Various portions of catheter 206 may be steerable.Catheter 206 may include one or more lumens, for example within theelongated shaft member. The lumen(s) may carry one or morecommunications or power paths, or both. For example, the lumens(s) maycarry one or more electrical conductors 216 (two shown in thisembodiment). Electrical conductors 216 provide electrical connections totransducer-based device 200 that are accessible externally from apatient in which the transducer-based device 200 is inserted. Thelumen(s) may carry various control elements (e.g., control lines)operatively coupling one or more actuators to a manipulable portion(e.g., manipulable portion 200)

In various embodiments, transducer-based device, or manipulable portion,200 includes a frame or structure 218, which assumes an unexpandedconfiguration for delivery to left atrium 204. Structure 218 is expanded(i.e., shown in a deployed or expanded configuration in FIG. 1) upondelivery to left atrium 204 to position a plurality of transducers 220(three called out in FIG. 1) proximate the interior surface formed bytissue 222 of left atrium 204. In this regard, it can be stated that oneor more of the transducers 220 are moveable with one or more parts ofthe transducer-based device, or manipulable portion, 200. In someembodiments, at least some of the transducers 220 are used to sense aphysical characteristic of a fluid (i.e., blood) or tissue 222, or both,that may be used to determine a position or orientation (i.e., pose), orboth, of a portion of transducer-based device 200 within, or withrespect to left atrium 204. For example, transducers 220 may be used todetermine a location of pulmonary vein ostia (not shown) or a mitralvalve 226, or both. In some embodiments, at least some of thetransducers 220 may be used to selectively ablate portions of the tissue222. For example, some of the transducers 220 may be used to ablate apattern or path around various ones of the bodily openings, ports orpulmonary vein ostia, for instance to reduce or eliminate the occurrenceof atrial fibrillation.

FIGS. 2A and 2B show a catheter system (i.e., a portion thereof shownschematically) that includes a transducer-based device 300 according toone illustrated embodiment. The transducer-based device 300 maycorrespond to the transducer-based device 200 and, in this regard, mayalso be referred to as a manipulable portion, due to its ability to haveits size, shape, or both size and shape altered, according to someembodiments described below. Transducer-based device 300 may include aplurality of elongate members 304 (three called out in each of FIGS. 2Aand 2B) and a plurality of transducers 306 (three called out in FIG. 2A,and three called out in FIG. 2B as 306 a, 306 b, and 306 c). As willbecome apparent, the plurality of transducers 306 is positionable withina bodily cavity. For example, in some embodiments, the transducers 306can be positioned in a bodily cavity by movement into, within, or intoand within the bodily cavity, with or without a change in a particularconfiguration of the plurality of transducers 306. In some embodiments,the plurality of transducers 306 are arrangeable to form a two- orthree-dimensional distribution, grid or array of the transducers capableof mapping, ablating, or stimulating an inside surface of a bodilycavity or lumen without requiring mechanical scanning. As shown, forexample, in FIG. 2A, the plurality of transducers 306 are arranged in adistribution receivable in a bodily cavity, as the transducer-baseddevice 300 and its plurality of transducers 306 are located within thecatheter sheath 312. Stated differently, in FIG. 2A, for example, theplurality of transducers 306 are arranged in a distribution suitable fordelivery to a bodily cavity. (It should also be noted, however, that theexpanded or deployed configuration (e.g., FIGS. 1, 2B, 4A, 6B) may alsobe considered to have the transducers 306 arranged in a distributionreceivable in a bodily cavity, as the transducer-based device 300 andits transducers 306 may be returned to the delivery configuration ofFIGS. 2A, 4B for example). In some embodiments, each of the transducers306 includes an electrode 315 (one called out in FIG. 2B) having anenergy transmission surface 319 (one called out in FIG. 2B) suitable fortransmitting energy in various directions. In some embodiments,tissue-ablating energy is transmitted toward or away from an electrode315. In some embodiments, tissue-based electrophysiological energy istransmitted toward an electrode 315.

The elongate members 304 form part of a manipulable portion, and invarious embodiments, are arranged in a frame or structure 308 that isselectively moveable between an unexpanded or delivery configuration(i.e., as shown in FIG. 2A) and an expanded or deployed configuration(i.e., as shown in FIG. 2B) that may be used to position elongatemembers 304 against a tissue surface within the bodily cavity orposition the elongate members 304 in the vicinity of or in contact withthe tissue surface. In this regard, it may also be stated that thetransducer-based device, or manipulable portion, 300 is selectivelymoveable between an unexpanded or delivery configuration (i.e., as shownin FIG. 2A) and an expanded or deployed configuration (i.e., as shown inFIG. 2B). In some embodiments, the transducer-based device, ormanipulable portion, 300, (e.g., the structure 308 thereof) has a size,shape, or both a size and a shape in the unexpanded or deliveryconfiguration suitable for percutaneous delivery through a bodilyopening (for example, via an elongate shaft member such as cathetersheath 312, not shown in FIG. 2B) to the bodily cavity. In someembodiments, structure 308 has a size, shape, or both a size and a shapein the expanded or deployed configuration too large for percutaneousdelivery through a bodily opening (i.e., via catheter sheath 312) to thebodily cavity. The elongate members 304 may form part of a flexiblecircuit structure (i.e., also known as a flexible printed circuit board(PCB)). The elongate members 304 may include a plurality of differentmaterial layers, and each of the elongate members 304 may include aplurality of different material layers. The structure 308 may include ashape memory material, for instance Nitinol. The structure 308 mayinclude a metallic material, for instance stainless steel, ornon-metallic material, for instance polyimide, or both a metallic andnon-metallic material by way of non-limiting example. The incorporationof a specific material into structure 308 may be motivated by variousfactors including the specific requirements of each of the unexpanded ordelivery configuration and expanded or deployed configuration, therequired position or orientation (i.e., pose) or both of structure 308in the bodily cavity, or the requirements for successful ablation of adesired pattern. The number of elongate members depicted in FIG. 2B isnon-limiting.

FIG. 3 is a schematic side elevation view of at least a portion of atransducer-based device 400 that includes a flexible circuit structure401 that is employed to provide a plurality of transducers 406 (twocalled out) according to an example embodiment. In some embodiments, theflexible circuit structure 401 may form part of a structure (e.g.,structure 308) that is selectively moveable between an unexpanded ordelivery configuration sized for percutaneous delivery and an expandedor deployed configuration sized too large for percutaneous delivery. Insome embodiments, the flexible circuit structure 401 may be located on,or form at least part of, of a structural component (e.g., elongatemember 304) of a transducer-based device system.

The flexible circuit structure 401 may be formed by various techniquesincluding flexible printed circuit techniques. In some embodiments, theflexible circuit structure 401 includes various layers includingflexible layers 403 a, 403 b, and 403 c (i.e., collectively flexiblelayers 403). In some embodiments, each of flexible layers 403 includesan electrical insulator material (e.g., polyimide). One or more of theflexible layers 403 may include a different material than another of theflexible layers 403. In some embodiments, the flexible circuit structure401 includes various electrically conductive layers 404 a, 404 b, and404 c (collectively electrically conductive layers 404) that areinterleaved with the flexible layers 403. In some embodiments, each ofthe electrically conductive layers 404 is patterned to form variouselectrically conductive elements. For example, electrically conductivelayer 404 a is patterned to form a respective electrode 415 of each ofthe transducers 406. Electrodes 415 have respective electrode edges415-1 that form a periphery of an electrically conductive surfaceassociated with the respective electrode 415. FIG. 2B shows anotherexample of electrode edges 315-1 and illustrates that the electrodeedges can define electrically conductive surface peripheries of variousshapes.

Returning to FIG. 3, electrically conductive layer 404 b is patterned,in some embodiments, to form respective temperature sensors 408 for eachof the transducers 406 as well as various leads 410 a arranged toprovide electrical energy to the temperature sensors 408. In someembodiments, each temperature sensor 408 includes a patterned resistivemember 409 (two called out) having a predetermined electricalresistance. In some embodiments, each resistive member 409 includes ametal having relatively high electrical conductivity characteristics(e.g., copper). In some embodiments, electrically conductive layer 404 cis patterned to provide portions of various leads 410 b arranged toprovide an electrical communication path to electrodes 415. In someembodiments, leads 410 b are arranged to pass though vias in flexiblelayers 403 a and 403 b to connect with electrodes 415. Although FIG. 3shows flexible layer 403 c as being a bottom-most layer, someembodiments may include one or more additional layers underneathflexible layer 403 c, such as one or more structural layers, such as asteel or composite layer. These one or more structural layers, in someembodiments, are part of the flexible circuit structure 401 and may bepart of, e.g., elongate member 304. In addition, although FIG. 3 showsonly three flexible layers 403 a-403 c and only three electricallyconductive layers 404 a-404 c, it should be noted that other numbers offlexible layers, other numbers of electrically conductive layers, orboth, may be included.

In some embodiments, electrodes 415 are employed to selectively deliverRF energy to various tissue structures within a bodily cavity (e.g., anintra-cardiac cavity). The energy delivered to the tissue structures maybe sufficient for ablating portions of the tissue structures. The energydelivered to the tissue may be delivered to cause monopolar tissueablation, bipolar tissue ablation or blended monopolar-bipolar tissueablation by way of non-limiting example.

Energy that is sufficient for tissue ablation may be dependent uponfactors including tissue characteristics, transducer location, size,shape, relationship with respect to another transducer or a bodilycavity, material or lack thereof between transducers, etc.

In some embodiments, each electrode 415 is employed to sense anelectrical potential in the tissue proximate the electrode 415. In someembodiments, each electrode 415 is employed in the generation of anintra-cardiac electrogram. In some embodiments, each resistive member409 is positioned adjacent a respective one of the electrodes 415. Insome embodiments, each of the resistive members 409 is positioned in astacked or layered array with a respective one of the electrodes 415 toform at least part of a respective one of the transducers 406. In someembodiments, the resistive members 409 are connected in series to allowelectrical current to pass through all of the resistive members 409. Insome embodiments, leads 410 a are arranged to allow for a sampling ofelectrical voltage in between each resistive member 409. Thisarrangement allows for the electrical resistance of each resistivemember 409 to be accurately measured. The ability to accurately measurethe electrical resistance of each resistive member 409 may be motivatedby various reasons including determining temperature values at locationsat least proximate the resistive member 409 based at least on changes inthe resistance caused by convective cooling effects (e.g., as providedby blood flow). In some embodiments in which the transducer-based deviceis deployed in a bodily cavity (e.g., when the transducer-based device300 is part of a catheter system and may be arranged to bepercutaneously or intravascularly delivered to a bodily cavity via acatheter), it may be desirable to perform various mapping procedures inthe bodily cavity. For example, when the bodily cavity is anintra-cardiac cavity, a desired mapping procedure may include mappingelectrophysiological activity in the intra-cardiac cavity. Other desiredmapping procedures may include mapping of various anatomical featureswithin a bodily cavity. An example of the mapping performed by devicesaccording to various embodiments may include locating the position ofthe ports of various bodily openings positioned in fluid communicationwith a bodily cavity. For example, in some embodiments, it may bedesired to determine the locations of various ones of the pulmonaryveins or the mitral valve that each interrupts an interior surface of anintra-cardiac cavity such as a left atrium.

Referring to FIGS. 2A, 2B, transducer-based device or manipulableportion 300 may communicate with, receive power from, or be controlledby a control system 322. In some embodiments, elongate members 304 mayform a portion of an elongated cable 316 of control leads 317, forexample by stacking multiple layers, and terminating at a connector 321or other interface with control system 322. The control leads 317 maycorrespond to the electrical connectors 216 in FIG. 1 in someembodiments. The control system 322 may include a controller 324 thatmay include a data processing device system 310 and a memory devicesystem 330 that stores data and instructions that are executable by thedata processing device system 310 to process information received fromtransducer-based device 300 or to control operation of transducer-baseddevice 300, for example activating various selected transducers 306 toablate tissue. Controller 324 may include one or more controllers.

In some embodiments, the controller 324 may be configured to controldeployment, expansion, retraction, or other manipulations of the shape,positioning, or both shape and positioning of the transducer-baseddevice (e.g., manipulable portion) 300 at least by driving (e.g., by anelectric or other motor) movement of various actuators or other cathetersystem components. In this regard, in some embodiments, the controller324 is at least part of a control system, which may include one or moreactuators, configured to advance at least part of the transducer-baseddevice (e.g., 200, 300, 400, or 502), at least a portion of which may beconsidered a manipulable portion, out of the catheter sheath 312,retract at least part of the transducer-based device back into thecatheter sheath 312, expand, contract, or otherwise change at least partof the shape of the transducer-based device.

Control system 322 may include an input-output device system 320communicatively connected to the data processing device system 310(i.e., via controller 324 in some embodiments). Input-output devicesystem 320 may include a user-activatable control that is responsive toa user action. Input-output device system 320 may include one or moreuser interfaces or input/output (I/O) devices, for example one or moredisplay device systems 332, speaker device systems 334, keyboards, mice,joysticks, track pads, touch screens or other transducers to transferinformation to, from, or both to and from a user, for example a careprovider such as a health care provider or technician. For example,output from a mapping process may be displayed on a display devicesystem 332.

Control system 322 may also include an energy source device system 340including one or more energy source devices connected to transducers306. In this regard, although FIG. 2A shows a communicative connectionbetween the energy source device system 340 and the controller 324 (andits data processing device system 310), the energy source device system340 may also be connected to the transducers 306 via a communicativeconnection that is independent of the communicative connection with thecontroller 324 (and its data processing device system 310). For example,the energy source device system 340 may receive control signals via thecommunicative connection with the controller 324 (and its dataprocessing device system 310), and, in response to such control signals,deliver energy to, receive energy from, or both deliver energy to andreceive energy from one or more of the transducers 306 via acommunicative connection with such transducers 306 (e.g., via one ormore communication lines through elongate shaft member 314, elongatedcable 316 or catheter sheath 312) that does not pass through thecontroller 324. In this regard, the energy source device system 340 mayprovide results of its delivering energy to, receiving energy from, orboth delivering energy to and receiving energy from one or more of thetransducers 306 to the controller 324 (and its data processing devicesystem 310) via the communicative connection between the energy sourcedevice system 340 and the controller 324.

In any event, the number of energy source devices in the energy sourcedevice system 340 may be fewer than the number of transducers in someembodiments. The energy source device system 340 may, for example, beconnected to various selected transducers 306 to selectively provideenergy in the form of electrical current or power (e.g., RF energy),light or low temperature fluid to the various selected transducers 306to cause ablation of tissue. The energy source device system 340 may,for example, selectively provide energy in the form of electricalcurrent to various selected transducers 306 and measure a temperaturecharacteristic, an electrical characteristic, or both at a respectivelocation at least proximate each of the various transducers 306. Theenergy source device system 340 may include as its energy source devicesvarious electrical current sources or electrical power sources. In someembodiments, an indifferent electrode 326 is provided to receive atleast a portion of the energy transmitted by at least some of thetransducers 306. Consequently, although not shown in FIG. 2A, theindifferent electrode 326 may be communicatively connected to the energysource device system 340 via one or more communication lines in someembodiments. In addition, although shown separately in FIG. 2A,indifferent electrode 326 may be considered part of the energy sourcedevice system 340 in some embodiments. In some embodiments, theindifferent electrode 326 is provided outside the body or at least thebodily cavity in which the transducer-based device (e.g., 200, 300, 400,or 502) or catheter system 500 is, at least in part, located.

In some embodiments, the energy source device system 340 may include oneor more driving motors configured to drive movement, in response toinstructions from the controller 324, of various actuators or othercatheter system components to control deployment, expansion, retraction,or other manipulations of the shape, positioning, or both shape andpositioning of the transducer-based device (e.g., manipulable portion)300.

It is understood that input-output device system 320 may include othersystems. In some embodiments, input-output device system 320 mayoptionally include energy source device system 340, transducer-baseddevice 300 or both energy source device system 340 and transducer-baseddevice 300 by way of non-limiting example.

Structure 308 of transducer-based device 300 may be delivered andretrieved through a catheter member, for example, a catheter sheath 312.In some embodiments, the structure 308 provides expansion andcontraction capabilities for a portion of a medical device (e.g., anarrangement, distribution or array of transducers 306). The transducers306 may form part of, be positioned or located on, mounted or otherwisecarried on the structure and the structure may be configurable to beappropriately sized to slide within a lumen of catheter sheath 312 inorder to be deployed percutaneously or intravascularly. FIG. 2A showsone embodiment of such a structure. In some embodiments, each of theelongate members 304 includes a respective distal end 305 (only onecalled out), a respective proximal end 307 (only one called out) and anintermediate portion 309 (only one called out) positioned between theproximal end 307 and the distal end 305. The respective intermediateportion 309 of each elongate member 304 includes a first or frontsurface 318 a that is positionable to face an interior tissue surfacewithin a bodily cavity and a second or back surface 318 b oppositeacross a thickness of the intermediate portion 309 from the frontsurface 318 a. In various embodiments, the intermediate portion 309 ofeach of the elongate members 304 includes a respective pair of sideedges of the front surface 318 a, the back surface 318 b, or both thefront surface 318 a and the back surface 318 b, the side edges of eachpair of side edges opposite to one another, the side edges of each pairof side edges extending between the proximal end 307 and the distal end305 of the respective elongate member 304. In some embodiments, eachpair of side edges includes a first side edge 327 a (only one called outin FIG. 2A) and a second side edge 327 b (only one called out in FIG.2A). In some embodiments, each of the elongate members 304, includingeach respective intermediate portion 309, is arranged front surface 318a-toward-back surface 318 b in a stacked array during an unexpanded ordelivery configuration (e.g., FIG. 2A, 5B). In many cases, a stackedarray allows the structure 308 to have a suitable size for percutaneousor intravascular delivery. A stacked array can allow structure 308 tohave a spatially efficient size for delivery through a lumen of cathetersheath 312. In some embodiments, the elongate members 304 are arrangedto be introduced into a bodily cavity distal end 305 first. For clarity,not all of the elongate members 304 of structure 308 are shown in FIG.2A. A flexible catheter body or elongate shaft member 314 is used todeliver structure 308 through catheter sheath 312. In some embodiments,each elongate member includes a twisted portion proximate proximal end307 (e.g., also FIG. 4B, discussed below).

In some embodiments, each of the elongate members 304 is arranged in afanned arrangement 370 in FIG. 2B. In some embodiments, the fannedarrangement 370 is formed during the expanded or deployed configurationin which the transducer-based device (e.g., manipulable portion) 300 orstructure 308 thereof is manipulated to have a size, shape, or both sizeand shape too large for percutaneous or intravascular delivery, forexample a size, shape, or both size and shape too large for percutaneousor intravascular delivery toward a bodily cavity, or a size, shape, orboth size and shape too large for percutaneous or intravascular deliveryaway from a bodily cavity. In some embodiments, the fanned arrangement370 is formed during the expanded or deployed configuration in which thetransducer-based device (e.g., manipulable portion) 300 or structure 308thereof is manipulated to have a size, shape, or both size and shape toolarge for delivery through a lumen of catheter sheath 312, for example,a size, shape, or both size and shape too large for delivery through alumen of catheter sheath 312 toward a bodily cavity, or a size, shape,or both size and shape too large for delivery through a lumen ofcatheter sheath 312 away from a bodily cavity.

In some embodiments, the transducer-based device (e.g., manipulableportion) 300 or structure 308 thereof includes a proximal portion 308 ahaving a first domed shape 309 a and a distal portion 308 b having asecond domed shape 309 b when the transducer-based device (e.g.,manipulable portion) 300 or structure 308 thereof is in the expanded ordeployed configuration. In some embodiments, the proximal and the distalportions 308 a, 308 b include respective portions of elongate members304. In some embodiments, the transducer-based device (e.g., manipulableportion) 300 or structure 308 thereof is arranged to be delivered oradvanced distal portion 308 b first (e.g., distal portion 308 b ahead ofproximal portion 308 a) into a bodily cavity when the transducer-baseddevice (e.g., manipulable portion) 300 or structure 308 thereof is inthe unexpanded or delivery configuration as shown in FIG. 2A. In someembodiments, the proximal and the distal portions 308 a, 308 b arearranged in a clam shell configuration in the expanded or deployedconfiguration shown in FIG. 2B. In various example embodiments, each ofthe front surfaces 318 a (two called out in FIG. 2B) of the intermediateportions 309 of the plurality of elongate members 304 face outwardlyfrom the structure 308 when the structure 308 is in the deployedconfiguration. In various example embodiments, each of the frontsurfaces 318 a of the intermediate portions 309 of the plurality ofelongate members 304 are positioned adjacent an interior tissue surfaceof a bodily cavity in which the structure 308 (i.e., in the deployedconfiguration) is located. In various example embodiments, each of theback surfaces 318 b (two called out in FIG. 2B) of the intermediateportions 309 of the plurality of elongate members 304 face an inwarddirection when the structure 308 is in the deployed configuration.

The transducers 306 may be arranged in various distributions orarrangements in various embodiments. In some embodiments, various onesof the transducers 306 are spaced apart from one another in aspaced-apart distribution in the delivery configuration shown in FIG.2A. In some embodiments, various ones of the transducers 306 arearranged in a spaced-apart distribution in the deployed configurationshown in FIG. 2B. In some embodiments, various pairs of transducers 306are spaced apart with respect to one another. In some embodiments,various regions of space are located between various pairs of thetransducers 306. For example, in FIG. 2B the transducer-based device 300includes at least a first transducer 306 a, a second transducer 306 b,and a third transducer 306 c (all collectively referred to astransducers 306). In some embodiments each of the first, the second, andthe third transducers 306 a, 306 b, and 306 c are adjacent transducersin the spaced apart distribution. In some embodiments, the first and thesecond transducers 306 a, 306 b are located on different elongatemembers 304 while the second and the third transducers 306 b, 306 c arelocated on a same elongate member 304. In some embodiments, a firstregion of space 350 is between the first and the second transducers 306a, 306 b. In some embodiments, the first region of space 350 is notassociated with any physical portion of structure 308. In someembodiments, a second region of space 360 associated with a physicalportion of device 300 (i.e., a portion of an elongate member 304) isbetween the second and the third transducers 306 b, 306 c. In someembodiments, each of the first and the second regions of space 350, 360does not include a transducer of transducer-based device 300. In someembodiments, each of the first and the second regions of space 350, 360does not include any transducer. It is noted that other embodiments neednot employ a group of elongate members 304 as employed in theillustrated embodiment. For example, other embodiments may employ astructure having one or more surfaces, at least a portion of the one ormore surfaces defining one or more openings in the structure. In theseembodiments, a region of space not associated with any physical portionof the structure may extend over at least part of an opening of the oneor more openings. In other example embodiments, other structures may beemployed to support or carry transducers of a transducer-based devicesuch as a transducer-based catheter device. For example, an elongatedcatheter member may be used to distribute the transducers in a linear orcurvilinear array. Basket catheters or balloon catheters may be used todistribute the transducers in a two-dimensional or three-dimensionalarray.

In some embodiments, a manipulable portion, such as, but not limited to,a transducer-based device (e.g., 200, 300, 400, or 502) is manipulatedto transition between an unexpanded or delivery configuration (e.g.,FIG. 2A) and an expanded or deployed configuration (e.g., FIG. 2B)manually (e.g., by a user's manual operation) or at least in part by wayof motor-based driving (e.g., from the energy source device system 340)of one or more actuators. Motor-based driving may augment or otherwisebe in response to manual actions, may be responsive to automated controlof a data processing device system (e.g., 310 in FIGS. 2A and 2B), ormay use a hybrid manual-automated approach.

In this regard, FIG. 4 show some or all of a catheter system 500, whichincludes a manipulable portion 502, according to various embodiments. Inthis regard, it should be noted that any of the catheter systemsdescribed herein may also be referred to as a medical system or medicaldevice system and, consequently, that catheter or catheter device system500 may be referred to as a medical or medical device system 500. Insome embodiments, the manipulable portion 502 corresponds to thetransducer-based device 200 or 300, although the manipulable portion 502need not be a transducer-based device and may be some other form ofcatheter-based manipulable portion (e.g., a stent or other implant). Inthis regard, the systems of FIG. 4 (as well as the other remainingfigures) may be particular implementations of the systems of FIGS. 1 and2, according to some embodiments. Accordingly, descriptions hereinregarding the systems of FIGS. 1 and 2 apply to the systems of FIG. 4(as well as the other remaining figures), according to some embodiments.

As shown in FIG. 4A, catheter system 500 includes various devicesincluding a catheter 510, which includes a catheter shaft member 500 a(also referred to as elongate shaft member 500 a) (e.g., the same orsimilar to catheter body 314) according to various embodiments. In someembodiments, catheter system 500 (which may also be referred to as acatheter) includes a catheter sheath member 500 b (also referred to aselongate shaft member 500 b).

Elongate shaft member 500 a includes proximal end portion 510 f thatincludes a proximal end 510 a of the elongate shaft member 500 a; adistal end portion 510 e that includes a distal end 510 b of theelongate shaft member 500 a; and an intermediate or elongated portion510 c extending between the proximal end 510 a and the distal end 510 b(e.g., extending along the elongate shaft member 510 a along a path thatconnects proximal end 510 a and distal end 510 b). In some embodiments,the distal end 510 b is arranged to be deliverable ahead of the proximalend 510 a through a bodily opening leading to a bodily cavity. Invarious embodiments, elongate shaft member 500 a includes one or morelumens, each of at least some of the one or more lumens extendingbetween proximal end 510 a and distal end 510 b (e.g., extending alongthe elongate shaft member 510 a along a path that connects proximal end510 a and distal end 510 b). In various embodiments associated withvarious ones of FIG. 4, elongate shaft member 500 a includes a firstlumen 510 d extending between (or connecting, in some embodiments)proximal end 510 a and distal end 510 b. In some embodiments, the firstlumen 510 d includes a first end located at or proximate the proximalend 510 a and a second end located at or proximate the distal end 510 b.The second end of the first lumen 510 d may be included in the distalend portion 510 e of the elongate shaft member 500 a. In someembodiments associated with various ones of

FIG. 4, the manipulable portion 502 is connected to the distal endportion 510 e of the elongate shaft member 500 a at a location at orproximate the distal end 510 b. In some embodiments, the manipulableportion 502 is physically coupled or otherwise coupled to the distal endportion 510 e. In various embodiments, each of the proximal end portion510 f and the distal end portion 510 e includes a respective exteriorsurface or surface portion (e.g., a circumferential or cylindricalexterior surface or surface portion) of the elongate shaft member 500 a.

Elongate shaft member 500 b forms part of a catheter sheath 512 (e.g.,the same or similar to sheath 312) and includes a proximal end portion512 f that includes a proximal end 512 a of the elongate shaft member500 b; a distal end portion 512 e that includes a distal end 512 b ofthe elongate shaft member 500 b; and an intermediate or body portion 512c between the proximal end 512 a and the distal end 512 b. It is notedthat FIG. 4A shows two instances of the proximal end 512 a, as suchproximal end 512 a may be considered to be in either location or at alocation within a coupling assembly 511 a, depending upon theembodiment. In some embodiments, the distal end 512 b is arranged to bedeliverable ahead of the proximal end 512 a through a bodily openingleading to a bodily cavity. In various embodiments, elongate shaftmember 500 b includes one or more lumens, each of at least some of theone or more lumens extending between proximal end 512 a and distal end512 b (e.g., extending along the elongate shaft member 500 b along apath that connects proximal end 512 a and distal end 512 b). In variousembodiments associated with various ones of FIG. 4, elongate shaftmember 500 b includes a first lumen 512 d extending between (orconnecting, in some embodiments) proximal end 512 a and distal end 512b. In some embodiments, the first lumen 512 d includes a first endlocated at or proximate the proximal end 512 a and a second end locatedat or proximate the distal end 512 b. The second end of the first lumen512 d may be included in the distal end portion 512 e of the elongateshaft member 500 b. In various embodiments, each of the proximal endportion 512 f and the distal end portion 512 e includes a respectiveexterior surface or surface portion (e.g., a circumferential orcylindrical exterior surface or surface portion) of the elongate shaftmember 500 b.

In various embodiments, elongate shaft member 500 b provides apassageway for at least a portion of elongate shaft member 500 a to bedelivered therethrough to a location within a body during a medicalprocedure. In some embodiments, elongate shaft member 500 b is deployedpercutaneously or intravascularly into a body. In various embodiments,at least a portion of elongate shaft member 500 b (e.g., at least aportion of the catheter sheath 512) is delivered distal end 512 b first(e.g., ahead of the proximal end 512 a) through a naturally occurringbodily opening toward a bodily cavity. For instance, the catheter sheath512 may be receivable in, insertable into, or positionable in a bodilyopening. In some embodiments, the bodily opening is accessed by anatural orifice or port provided by the body. In some embodiments, thebodily opening is accessed by a perforation made in bodily tissue. Invarious embodiments, a portion or part of elongate shaft member 500 a(e.g., at least part of the catheter 510) is received in, receivable in,or sized for delivery through the first lumen 512 d of the elongateshaft member 500 b to a bodily cavity or to deliver the manipulableportion 502 through the first lumen 512 d of the elongate shaft member500 b to a bodily cavity (e.g., a bodily vessel, chamber or cavitywithin a bodily organ). In this regard, in some embodiments, at leastpart of the elongate shaft member 500 a including the distal end 510 bis sized for delivery through a bodily opening leading to a bodilycavity located in a body.

It is understood that, although each of elongate shaft member 500 a andelongate shaft member 500 b is depicted in FIG. 4A in an essentiallystraight configuration, each of elongate shaft member 500 a (or at leastpart of the elongate shaft member 500 a receivable in the lumen 512 d ofthe elongate shaft member 500 b) and elongate shaft member 500 b may beflexible or bendable or may include one or more flexible or bendableportions that allow bending or deflection or the assumption of a bent orcurved (e.g., arcuate) form, e.g., during or for delivery to a bodilycavity. It is further understood that each of elongate shaft member 500a and elongate shaft member 500 b may include a respective longitudinalaxis extending between the respective ones of proximal ends 510 a, 512 aand respective ones of distal ends 510 b, 512 b. As each of the elongateshaft members 500 a, 500 b may, according to various embodiments, assumea bent or arcuate form, their respective longitudinal axes may alsoassume a corresponding bent or arcuate form.

In various embodiments, elongate shaft member 500 a is arranged withrespect to elongate shaft member 500 b such that the distal end 510 b ofelongate shaft member 500 a is configured, arranged, or sized to bedelivered through the first lumen 512 d of elongate shaft member 500 bprior to at least the elongated portion 510 c of the elongate shaftmember 500 a, when the distal end 510 b of the elongate shaft member 500a is delivered toward or to the bodily cavity. In various embodiments,elongate shaft member 500 a of catheter 510 is arranged with respect tothe elongate shaft member 500 b of catheter sheath 512 such that thedistal end 510 b of shaft 500 a is configured, arranged, or sized to bedelivered through the first lumen 512 d of the elongate shaft member 500b in a direction extending from the proximal end 512 a of elongate shaftmember 500 b toward the distal end 512 b of elongate shaft member 500 bwhen the distal end 510 b of elongate shaft member 500 a is deliveredtoward or to the bodily cavity.

In various embodiments, the manipulable portion 502 includes a proximalend portion 501 a (e.g., in the vicinity of elongate member proximalends 507 in FIG. 4B), a distal end portion 501 b (e.g., in the vicinityof elongate member distal ends 505 in FIG. 4B), and an elongated portion501 c (e.g., FIG. 4B) extending between the proximal end portion 501 aand the distal end portion 501 b of the manipulable portion 502. In someembodiments, the manipulable portion 502 is delivered and advancedoutwardly, (e.g., distal end portion 501 b first with respect to or ascompared to other parts of the manipulable portion 502), through thefirst lumen 512 d of the elongate shaft member 500 b of catheter sheath512 toward or to the bodily cavity as the elongate shaft member 500 a isadvanced accordingly through first lumen 512 d.

It is noted that each of elongate shaft member 500 a and elongate shaftmember 500 b has a respective elongated portion that can havelongitudinal or axial components. For example, the elongate shaft member500 a has a longitudinal length 510 g from the proximal end 510 a to thedistal end 510 b, according to some embodiments. In some embodiments,the longitudinal length 510 g is sufficient to position the proximal end510 a outside a body including a bodily cavity during a state in whichthe distal end 510 b (or the manipulable portion 502) is positioned inthe bodily cavity. Similarly, the elongate shaft member 500 b has alongitudinal length 512 g from the proximal end 512 a to the distal end512 b, according to some embodiments. In some embodiments, thelongitudinal length 512 g is sufficient to position the proximal end 512a outside a body including a bodily cavity during a state in which thedistal end 512 b (or the manipulable portion 502) is positioned in thebodily cavity. As used in this disclosure, words such as “longitudinal”or “axial” are not limited to various members having generally straightforms but may include members that have bent or arcuate forms or formsthat have been bent from a generally straight form into a generallynon-straight form.

In various embodiments, manipulable portion 502 is selectivelyconfigurable or moveable, e.g., based at least upon user (e.g., a healthcare provider, technician, or other user) input (e.g., by way of variousactuators provided in or on housing 520 of catheter, such as actuator520 a discussed below). For example, in some embodiments, themanipulable portion 502 may form at least part of a steerable portion ofelongate shaft member 500 a. Catheter devices employing steerableportions may be used to better negotiate tortuous paths sometimesencountered during delivery to a bodily cavity. Catheter devicesemploying steerable portions may be employed to better achieve a desiredpositioning of various devices (e.g., implants or transducer systems).In some embodiments, the manipulable portion 502 may be selectivelydetachable from the elongate shaft member 500 a. For example, themanipulable portion 502 may, in some embodiments, form part of animplant (e.g., a stent). In some of these embodiments, an implantprovided at least in part by the manipulable portion 502 may beselectively configurable or moveable (e.g., by way of a modulation orother actuator described in this disclosure) between a deliveryconfiguration in which the implant is appropriately sized for deliverythrough the first lumen 512 d toward or to a particular location in thebodily opening or bodily cavity and a deployed configuration in whichthe implant is sized too large for delivery through the first lumen 512d toward or to the particular location in the bodily opening or bodilycavity. In some of these embodiments, the implant may be positioned inthe deployed configuration when implanted or otherwise brought intoengagement with tissue (e.g., a stent that is selectively expanded togrip or to otherwise be secured within a bodily vessel).

In some embodiments associated with various ones of FIG. 4, manipulableportion 502 forms a part of a transducer-based device (e.g., 200, 300)with various sets of one or more transducers located on, or forming partof the manipulable portion 502. For example, in some embodiments,manipulable portion 502 includes a structure 502 a (e.g., the same orsimilar to structure or frame 308) and various transducers 506 (only onecalled out in FIG. 4B, and which may be the same or similar totransducers 220, 306, 406) that are located on or carried by themanipulable portion 502 or the structure 502 a thereof. In a manner thatis the same or similar to other embodiments described above in thisdisclosure, manipulable portion 502 or structure 502 a is selectivelyconfigurable or moveable (e.g., by way of a modulation or other actuatordescribed in this disclosure) between an unexpanded or deliveryconfiguration in which at least the manipulable portion 502 or structure502 a is appropriately sized, shaped, or both sized and shaped fordelivery through the first lumen 512 d of the elongate shaft member 500b of catheter sheath 512 at least toward or to a bodily cavity locatedin a body and an expanded or deployed configuration in which at leastthe structure 502 a is sized, shaped, or both sized and shaped too largefor delivery through the first lumen 512 d of the catheter sheath 512 atleast toward or to the bodily cavity. In some embodiments, a size,shape, or both size and shape of the manipulable portion 502 orstructure 502 a in the expanded or deployed configuration is or arelarger than a corresponding size, shape, or both size and shape of themanipulable portion 502 or structure 502 a in the unexpanded or deliveryconfiguration. In some embodiments, in the unexpanded or deliveryconfiguration, the manipulable portion 502 or structure 502 a is sizedto permit delivery of the manipulable portion 502 or structure 502 athrough a bodily opening leading to the bodily cavity, and in thedeployed or expanded configuration, the manipulable portion 502 orstructure 502 a is sized too large to permit delivery of the manipulableportion 502 or structure 502 a through the bodily opening leading to thebodily cavity.

In various embodiments, the manipulable portion 502 or structure 502 athereof is physically coupled or otherwise coupled to the elongate shaftmember 500 a at a location at least proximate the distal end 510 b ofthe elongate shaft member 500 a. In this regard, the manipulable portion502 or structure 502 a thereof may include a plurality of elongatemembers 504 (two called out in FIG. 4A), such as elongate members 304,that are physically coupled to elongate shaft member 500 a, which isemployed to transport the elongate members 504 through first lumen 512 dwhen the structure 502 a is in an unexpanded or delivery configuration.The number of elongate members 504 shown in various ones of FIG. 4 isnon-limiting.

Reference will now be made to FIG. 5, which illustrate, among otherthings, the flushing of the elongate shaft member 500 b of the cathetersheath 512, according to some embodiments. FIG. 6, discussed furtherbelow, illustrate, among other things, the flushing of the elongateshaft member 500 a of the catheter 510, according to some embodiments.In some embodiments, the elongate shaft member 500 a and the elongateshaft member 500 b are flushed at different times.

FIG. 5A illustrates at least a portion of a flushing kit 600 employed toflush a catheter according to various embodiments. The catheter mayinclude an elongate shaft member that includes a proximal end, a distalend and a length from the proximal end to the distal end. In thisregard, the catheter may be catheter 510. Also in this regard, theelongate shaft member may form part of a catheter sheath, such ascatheter sheath 312 or catheter sheath 512 (e.g., elongate shaft member500 b including proximal end 512 a and distal end 512 b). For ease ofdiscussion, and according to some embodiments in which flushing kit 600is employed with a catheter sheath, reference will be made to elongateshaft member 500 b although it is understood that other catheter sheathsmay be readily employed. As per another example, the elongate shaftmember may form part of a catheter, such as catheter 206, the cathetersystem of FIG. 3 (e.g., elongate shaft member 314), or catheter 510(e.g., elongate shaft member 500 b including proximal end 510 a anddistal end 510 b). For ease of discussion, and according to someembodiments in which flushing kit 600 is employed with a catheter,reference will be made to elongate shaft member 500 a, although it isunderstood that other catheters may be readily employed.

In various embodiments, as discussed above, the elongate shaft member500 a includes a first lumen 510 d. The first lumen 510 d may include afirst end at least proximate the proximal end 510 a of the elongateshaft member 500 a and may include a second end at least proximate thedistal end 510 b of the elongate shaft member 500 a. Similarly, theelongate shaft member 500 b of catheter sheath 512 may include a firstlumen 512 d including a first end located at least proximate theproximal end 512 a and may include a second end located at leastproximate the distal end 512 b of elongate shaft member 500 b. In thisregard, various lumens may be provided in elongate shaft member 500 a,elongate shaft member 500 b, or both, to provide a passageway forvarious control leads (e.g., control leads 317) that may extendtherethrough to various elongate members 304 or transducers 306 thereofthat may form part of manipulable portion 502. Various lumens may beadditionally or alternatively provided in elongate shaft member 500 a,elongate shaft member 500 b, or both, to provide a passageway forvarious control lines that may couple an actuator system (e.g., anactuator system provided in or on housing 520) to the manipulableportion 502 to selectively manipulate the manipulable portion 502 (e.g.,selectively manipulating the manipulable portion 502 between anunexpanded or delivery configuration and an expanded or deployedconfiguration). In various embodiments, the distal end (e.g., 510 b, 512b) of the elongate shaft member is arranged to be deliverable ahead ofthe proximal end (e.g., 510 a, 512 a) of the elongate shaft memberthrough a bodily opening leading to a bodily cavity or a bodily organ.In some embodiments, the manipulable portion 502 is located at thedistal end 510 b of the elongate shaft member 500 a or is located closerto the distal end 510 b of the elongate shaft member 500 a than it is tothe proximal end 510 a of the elongate shaft member 500 a. In someembodiments, the manipulable portion 502 is not located between thedistal end 510 b of the elongate shaft member 500 a and the proximal end510 a of the elongate shaft member 500 a. In some embodiments, thehousing 520 is located at the proximal end 510 a of the elongate shaftmember 500 a or is located closer to the proximal end 510 a of theelongate shaft member 500 a than it is to the distal end 510 b of theelongate shaft member 500 a. In some embodiments, the housing 520 is notlocated between the distal end 510 b of the elongate shaft member 500 aand the proximal end 510 a of the elongate shaft member 500 a. In someembodiments, the length (e.g., longitudinal length 510 g, 512 g) of theelongate shaft member is sufficient to position the proximal end (e.g.,510 a, 512 a) of the elongate shaft member outside a body that includesthe bodily cavity during a state in which the distal end (e.g., 510 b,512 b) of the elongate shaft member is positioned in the bodily cavity.

According to various embodiments, flushing kit 600 may include a vessel602 that includes an interior cavity 603 and a first port 605 in fluidcommunication with the interior cavity 603. In some embodiments, thefirst port 605 is considered to be not part of the vessel 602. In someembodiments, the vessel 602 includes a removable cap 604, the cap 604removable to provide access interior cavity 603. FIG. 5B is aperspective view of at least cap 604 according to various embodiments.FIG. 5C is an exploded perspective view of at least cap 604. In someembodiments, cap 604 may be completely removable (e.g., completelyseparable) from vessel 602 to permit or allow greater access to interiorcavity 603. In some embodiments, cap 604 may be partially removablewhile still being physically coupled (e.g., by a hinge or otherconnector) to vessel 602. In some embodiments associated with FIG. 5,cap 604 includes a first screw thread portion 604-1 (e.g., an internalscrew thread) that is threadedly couplable to a second screw threadportion 602-1 provided on vessel 602. A seal 604 c (e.g., a seal madefrom an elastomeric material, such as silicone or neoprene) may beemployed according to various embodiments to seal cap 604 to vessel 602.

The use of cap 604 may be motivated for various reasons. For example,cap 604 may be provided to allow a relatively larger access port to theinterior cavity 603 of the vessel 602 than any other port that may beprovided on the vessel 602. A relatively larger access port may beadvantageous to allow a required quantity of a liquid or other fluid tobe transferred to the interior cavity 603 in a timely or expeditiousmanner, according to some embodiments. A relatively larger access portmay be advantageous to allow other elements of the flushing kit 600(e.g., conduit member 606, described below) whose size, shape, or bothsize and shape would make it difficult to insert or otherwise positioninto interior cavity 603 via a port of a relatively smaller size.

In some embodiments, the first port 605 is sized to removably receive atleast part of the distal end portion (e.g., 510 e or 512 e, depending onwhich elongate shaft member 500 a or 500 b is being flushed) of theelongate shaft member (500 a or 500 b) to be flushed. In someembodiments, the phrase “removably receive” in this and similar contextsmeans that the port 605 is sized to receive the distal end portion ofthe elongate shaft member in a manner that does not permanently couplethe port 605 and the distal end portion of the elongate shaft member.For example, any coupling that may exist between the elongate shaftmember 500 a or 500 b and the vessel 602 once the distal end portion(e.g., 510 e or 512 e, depending on which elongate shaft member 500 a or500 b is being employed) of the elongate shaft member (500 a or 500 b)is received (e.g., inserted) in the first port 605 may be manipulated(for example, without the use of a tool or tools) to readily allowremoval of the distal end portion from the first port 605. In variousembodiments, the at least part of the distal end portion (e.g., 510 e,512 e) includes both the distal end (e.g., 510 b, 512 b) of the elongateshaft member and a second end or distal end of the first lumen extendingthrough the elongate shaft member. For example, in FIG. 4A, the distalend portion 512 e of the elongate shaft member 500 b includes the distalend 512 b of the elongate shaft member 500 b and the distal or secondend 512 d-1 of the first lumen 512 d of the elongate shaft member 500 b.

In various embodiments, the first port 605 is sized to permit deliveryof the manipulable portion 502 or structure 502 a through the first port605 when the manipulable portion 502 or structure 502 a is in theunexpanded or delivery configuration. In some embodiments, the firstport 605 is sized to restrict delivery of the manipulable portion 502 orstructure 502 a through the first port 605 when the manipulable portion502 or structure 502 a is in the expanded or deployed configuration.

In various embodiments, vessel 602 is configured to not be deliverable,or configured to be incapable of being deliverable, through the samebodily opening (e.g., via a percutaneous or intravascular delivery) thatthe elongate shaft member (500 a, 500 b) is configured for deliverythrough. For example, the vessel 602 may include a size (e.g., anoverall size or dimension) that is too large or renders the vessel 602too large for delivery of the vessel 602 through the bodily openingleading to a bodily cavity to which the elongate shaft member (500 a,500 b) is to be delivered. For example, in various ones of the FIG. 5,vessel 602 is sized much larger than a size of first port 605, which issized according to various embodiments to allow for a sliding fit withthe at least part of the distal end portion (e.g., 510 e, 512 e) of theelongate shaft member (e.g., 500 a, 500 b). Accordingly, the size of thefirst port 605 may approximate the size (e.g., at least be smaller thanthe size) of the bodily opening through which the elongate shaft member(500 a, 500 b) is to be delivered. Consequently, the vessel 602 may bephysically incapable of being delivered through such bodily openingbecause its size is much larger than that of the first port 605.

In some embodiments, vessel 602 may be incapable of being deliverablethrough the bodily opening in various states. For example, in someembodiments, the vessel 602 may include a size (e.g., an overall size ordimension) that is too large or renders the vessel 602 too large fordelivery of the vessel 602 through the bodily opening leading to abodily cavity to which the elongate shaft member (500 a, 500 b) is to bedelivered at least in a state in which a particular portion or theentirety of the interior cavity 603 is void of a particular liquid (forexample, a liquid as described below in this disclosure, such as aflushing liquid, e.g., saline). In some embodiments, the vessel 602 mayinclude a size (e.g., an overall size or dimension) that is too large orrenders the vessel 602 too large for delivery of the vessel 602 throughthe bodily opening at least in a state in which a particular portion orthe entirety of the interior cavity 603 is void of any particular liquid(e.g., void of any liquid whatsoever). In some embodiments, the vessel602 may include a size (e.g., an overall size or dimension) that is toolarge or renders the vessel 602 too large for delivery of the vessel 602through the bodily opening at least in a state in which a portion of theinterior cavity 603 in filled with a particular liquid and anotherportion of the interior cavity 603 is not filled with the particularliquid. Similarly, in some embodiments, the vessel 602 may include asize (e.g., an overall size or dimension) that is too large or rendersthe vessel 602 too large to fit in the bodily cavity to which theelongate shaft member (500 a, 500 b) is to be delivered at least in eachof one or more or all of the above-described states. For example, thevessel 602 may have the above-described size(s) at least in embodimentswhere the vessel 602 is formed of a rigid or substantially rigidstructure that may be incapable of fitting into the bodily cavity ordelivery though the bodily opening leading to the bodily cavityregardless of whether it is empty of liquid or filled at least in partwith liquid. FIG. 5A illustrates the vessel 602 having such a rigid orsubstantially rigid structure. According to some embodiments, the vessel602 illustrated in FIG. 5A is sufficiently rigid to not collapse atleast throughout execution of the methods described herein, whileallowing the walls of such vessel 602 to slightly expand outward orcompress inward depending upon the state of pressurization of the liquidtherein, as described herein. In some embodiments, the vessel 602 mayinclude a structure that is incapable of collapsing to a size suitablefor delivery through the bodily opening leading to the bodily cavity.For example, the vessel 602 may include a flexible structure that iscollapsible or compressible to a minimum size that is incapable ofallowing delivery of the vessel 602 through the bodily opening leadingto the bodily cavity.

Even if the vessel 602 is a flexible or substantially compliantstructure that may allow sufficient compression to possibly fit throughthe bodily opening, the mere presence of the vessel 602 during thedelivery of the elongate shaft member (e.g., 500 a, 500 b) through thebodily opening may impede, restrict, or prevent a required functioningof the elongate shaft member or catheter that comprises the elongateshaft member. For example, if the elongate shaft member is part of acatheter sheath (e.g., elongate shaft member 500 b), a delivery of anassembly including the elongate shaft member and vessel 602 (i.e.,positioned over the distal end portion (e.g., 512 e) of the elongateshaft member) through the bodily opening would likely position thevessel 602 so as to impede a subsequent delivery of the catheter orother medical instrument through a lumen of the elongate shaft member.If the elongate shaft member is part of a catheter (e.g., elongate shaftmember 500 a), a delivery of an assembly including the elongate shaftmember and vessel 602 (i.e., positioned over the distal end portion(e.g., 510 e) of the elongate shaft member) through the bodily openingwould likely position the vessel 602 so as to impede a subsequentoperation of manipulable portion 502 with respect to tissue within thebodily cavity (e.g., tissue ablation or the sensing of variousphysiological parameters such as tissue electrical potential). In thisregard, when the flushing kit 600 is employed, the at least part of thedistal end portion (e.g., 510 e, 512 e) of the elongate shaft member(e.g., 500 a, 500 b) inserted into the vessel 602 is removed from theinterior cavity 603 prior to a delivery of at least the distal endportion (e.g., 510 e, 512 e) of the elongate shaft member (e.g., 500 a,500 b) through the bodily opening leading to the bodily cavity,according to some embodiments.

Referring to the exploded view of FIG. 5C, the flushing kit 600includes, according to some embodiments, a seal or seal member 608arranged to selectively seal an exterior surface of a first part of thedistal end portion (e.g., 510 e, 512 e) of the elongate shaft member(e.g., 500 a, 500 b) to a portion of the vessel 602 at least in a statein which at least a second part of the distal end portion (e.g., 510 e,512 e) of the elongate shaft member (e.g., 500 a, 500 b) is positioned,via the first port 605, in the interior cavity 603 at a particularlocation in the interior cavity 603. In some embodiments, the portion ofthe vessel 602, which is sealed to the exterior surface of the firstpart of the distal end portion of the elongate shaft member, is aportion of cap 604. In some embodiments, the portion of the vessel 602,which is sealed to the exterior surface of the first part of the distalend portion of the elongate shaft member, is a portion or surface (e.g.,at least a radially-inward-facing cylindrical or circumferentialengagement surface, according to some embodiments) of the seal 608contacting or engaging the exterior surface of a part of the distal endportion 510 e or 512 e, whichever is being flushed. However, in someembodiments, the seal 608 is considered to be its own separate device ordevice system and is not considered part of the vessel 602. In someembodiments, the seal 608 is considered to be its own separate device ordevice system and is not considered part of the cap 604. Regardless, invarious embodiments, the seal 608 may be configured to establish a sealbetween the seal 608 and the first part of the distal end portion (e.g.,510 e, 512 e) of the elongate shaft member (e.g., 500 a, 500 b) and tofurther establish (e.g., concurrently) a seal between the seal 608 andthe portion of the vessel 602. In this regard, it is understood that thefirst part of the distal end portion (e.g., 510 e, 512 e) of theelongate shaft member (e.g., 500 a, 500 b) is still sealed to theportion of the vessel 602, according to some embodiments.

In some embodiments, the second part of the distal end portion of theelongate shaft member is a part inserted into the interior cavity 603via the first port 605 provided by the vessel 602. In variousembodiments, the second part of the distal end portion of the elongateshaft member that is positioned at the particular location in theinterior cavity 603 includes the distal end (510 b, 512 b) of theelongate shaft member being flushed (e.g., 500 a or 500 b) and thedistal or second end of the first lumen (e.g., 510 d, 512 d) thatextends through the elongate shaft member. For example, according tovarious embodiments, the second part of the distal end portion 512 e ofelongate shaft member 500 b includes the distal end 512 b of theelongate shaft member 500 b and the second end 512 d-1 of the firstlumen 512 d of the elongate shaft member 500 b. In various embodiments,the particular location in the interior cavity 603 is a location in theinterior cavity 603 suitable to supply liquid contained in interiorcavity 603 into the second end (e.g., 512 d-1) of the first lumen (e.g.,512 d, when elongate shaft member 500 b is being flushed). In variousembodiments, the particular location in the interior cavity 603 is alocation in the interior cavity 603 suitable to supply liquid (e.g.,saline or other flushing liquid) contained in interior cavity 603 intothe second end (e.g., 512 d-1) of the first lumen (e.g., 512 d) to flushthe first lumen (e.g., 512 d) of fluid (e.g., an undesired fluid such asair) other than the liquid in a direction through the first lumen (e.g.,512 d) extending from the second end (e.g., 512 d-1) of the first lumen(e.g., 512 d) toward or to the proximal or first end of the first lumen(e.g., 512 d).

In various embodiments, the exterior surface of the first part of thedistal end portion (e.g., 510 e, 512 e) of the elongate shaft member(e.g., 500 a, 500 b) that seal 608 engages is a circumferential exteriorsurface extending continuously around a longitudinal axis of theelongate shaft member (e.g., 500 a, 500 b, whichever is being flushed).In some embodiments, the exterior surface of the distal end portion(e.g., 510 e, 512 e) of the elongate shaft member (e.g., 500 a, 500 b)is a cylindrical surface. For example, in FIG. 5C, seal 608 is securedbetween a first body portion 604 a of cap 604 and a seal engaging member610 of cap 604, the seal engaging member, according to some embodiments,being coupled by a screw thread coupling to the first body portion 604a. For example, seal engaging member 610 may include a screw threadportion 610 a-2 (e.g., an external screw-thread portion) configured tothreadedly engage with a screw thread portion 604 a-2 (e.g., an internalscrew thread portion) of the first body portion 604 a. In variousembodiments, seal 608 is made from a compliant material (e.g., anelastomer such as silicone or neoprene). In various embodiments, seal608 includes an engagement surface 608 a-2 arranged to seal against theexterior surface of the distal end portion (e.g., 510 e, 512 e) of theelongate shaft member (e.g., 500 a, 500 b). In various embodiments, seal608 is arranged to seal against the exterior surface of the distal endportion (e.g., 510 e, 512 e) of the elongate shaft member (e.g., 500 a,500 b) when seal engaging member 610 is manipulated (e.g., turned orrotated) and compresses (e.g., via the screw thread engagement) seal 608to cause engagement surface 608 a-2 to seal against the exterior surfaceof the distal end portion (e.g., 510 e, 512 e) of the elongate shaftmember (e.g., 500 a, 500 b). Due at least to the manipulation of theseal engaging member 610, it may be considered that the seal 608selectively seals the exterior surface of the first part of the distalend portion (e.g., 510 e, 512 e) to a portion or part of the vessel 602.In various embodiments, seal 608 includes an inclined or tapered portion608 a-1 arranged to bear against an inclined or tapered portion 608 a-1(called out in FIG. 5D) to amplify the engagement forces between theengagement surface 608 a-2 of seal 608 and the exterior surface of thedistal end portion (e.g., 510 e, 512 e) of the elongate shaft member(e.g., 500 a, 500 b). It is noted that other exterior surfaces of thedistal end portion (e.g., 510 e, 512 e) of the elongate shaft member(e.g., 500 a, 500 b) may be additionally or alternatively sealed by seal608 according to various embodiments. For example, in some embodiments,a face surface of a distal end (e.g., 510 b, 512 b) of the elongateshaft member (e.g., 500 a, 500 b) may be sealed by seal 608. In someembodiments, seal 608 is arranged to hermetically seal the exteriorsurface of the distal end portion (e.g., 510 e, 512 e) of the elongateshaft member (e.g., 500 a, 500 b) to the vessel 602. In variousembodiments, cap 604 includes a second body portion 604 b that includesthreaded portion 604-1 arranged for screw thread coupling with vessel602. In various embodiments, second body portion 604 b is free to rotatewith respect to first body portion 604 a.

FIG. 8A is a block diagram representing a method 900 in which flushingkit 600 may be employed to establish a flow of at least some of a liquidcontained in the interior cavity 603 of the vessel through the firstlumen (e.g., 512 d) from the distal or second end (e.g., 512 d-1) of thefirst lumen toward, or to, a proximal or first end of the first lumen.According to some embodiments, method 900 is employed to flush acatheter that comprises an elongate shaft member (e.g., 500 b) of afluid other than the liquid in a direction from the distal end toward orto the proximal end of the first lumen. For ease of discussion, method900 will be described with respect to catheter sheath 512 and elongateshaft member 500 b. It is understood however that method 900 or variantsthereof may be employed with other catheters and elongate shaft members(e.g., catheter 510 and elongate shaft member 500 a).

In block 902, a quantity of liquid is provided into at least a firstportion (e.g., first portion 603-1 at least in FIG. 5E) of the interiorcavity 603 of vessel 602. In various embodiments, in which an undesiredfluid is to be flushed from the catheter, saline may be employed as theliquid. In various cardiac procedures, heparinized saline may beemployed as the liquid because of its enhanced anticoagulant properties.In various embodiments, the quantity of liquid is provided into thefirst portion of the interior cavity 603 in various manners. Forexample, in some embodiments, cap 604 is removed or otherwisemanipulated to provide access to the interior cavity 603 so as to allowthe liquid to be poured or otherwise delivered thereto. In someembodiments, the liquid is provided to the interior cavity 603 via anopening or port other than an opening provided access to by cap 604.

The quantity of liquid provided is sufficient to flush the first lumen512 d of a fluid other than the liquid from at least some of the firstlumen 512 d, in some embodiments, from the entirety of the first lumen512 d in some embodiments, and to additionally flush other components orelements of the catheter in some embodiments. In various embodiments,the quantity of liquid provided is sufficient to flush the first lumen512 d of a fluid other than the liquid from at least some of the firstlumen 512 d multiple times (e.g., two times or more, three times ormore, etc.). In some embodiments, the quantity of liquid provided issufficient to flush respective portions (e.g., first lumens) of each ofa plurality of catheter members. For example, the quantity of liquidprovided may be sufficient to fully flush at least catheter 510 andcatheter sheath 512. It may be considered, in some embodiments, that thefirst portion 603-1 of the interior cavity 603 of the vessel 602 issized to receive at least a quantity of liquid sufficient to flush atleast the first lumen of a fluid other than the liquid.

In block 904, at least part (portion 512 e-1) of distal end portion 512e of the elongate shaft member 500 b is inserted into the interiorcavity 603 via a first port (e.g., first port 605) provided by thevessel 602. For example, in FIG. 5E, the part 512 e-1 (including thedistal end 512 b and the second end 512 d-1 of the respective firstlumen 512 d) is inserted into the interior cavity 603 via a first port(e.g., first port 605) provided by the vessel 602. A first portion 603-1of the interior cavity 603 includes a liquid 612 (e.g., saline orheparinized saline that has been provided as per block 902), accordingto some embodiments. According to various embodiments, vessel 602 ispositioned or arranged to allow the second end 512 d-1 of the firstlumen 512 d to be in fluid communication with the liquid 612 provided inthe first portion 603-1 of the interior cavity 603, when the distal endportion 512 e of the elongate shaft member 500 b is inserted into theinterior cavity 603 via a first port 605. For example, the distal endportion 512 e may be positioned in the interior cavity 603 such that atleast the second end 512 d-1 of the first lumen 512 d is in contactwith, or is wetted by, the liquid 612 in the first portion 603-1 of theinterior cavity 603. In various embodiments, the distal end portion 512e may be positioned in the interior cavity 603 to readily allow orpermit a flow of the liquid 612 into the second end 512 d-1 of the firstlumen 512 d.

In block 906, a seal is established to seal an exterior surface (e.g., acircumferential or cylindrical surface portion) of a first part (e.g.,portion 512 e-2) of the distal end portion 512 e of the elongate shaftmember 500 b to at least a portion of the vessel 602. According tovarious embodiments, the seal may be established at least in a state inwhich at least a second part (e.g., portion 512 e-1) of the distal endportion 512 e is located (for example, via the actions of block 904) inthe interior cavity 603 at a location suitable to supply the liquid 612into the second end 512 d-1 of the first lumen 512 d. For example, inFIG. 5E a seal may be established by manipulating (e.g., turning orrotating) seal engaging member 610 in the appropriate direction tocompress seal 608 (for example as described above in this disclosure).It is noted that other sealing mechanisms and methods may be employed inother embodiments. In some embodiments, a hermetic seal is establishedbetween the exterior surface of a first part (e.g., portion 512 e-2) ofthe distal end portion 512 e of the elongate shaft member 500 b and aleast a portion of the vessel 602. In some embodiments, some leakage ofthe liquid 612 may be tolerable. In some embodiments, the seal engagingmember 610 may be manipulated (e.g., turned or rotated) to un-compressseal 608 and release the seal between the exterior surface of the firstpart (e.g., portion 512 e-2) of the distal end portion 512 e of theelongate shaft member 500 b and the at least the portion of the vessel602, for example, after the elongate shaft member 500 b has beenflushed.

In block 908, a flow of at least some of the liquid 612 in the firstportion 603-1 of the interior cavity 603 is established through thefirst lumen 512 d from the second end 512 d-1 of the first lumen 512 dtoward or to a proximal or first end of the first lumen 512 d. This flowof liquid 612 may be motivated for various reasons. In some embodiments,this flow of liquid 612 may be employed to flush a fluid (e.g., anundesired fluid such as air) other than the liquid 612 from the firstlumen 512 d.

The flow of at least some of the liquid 612 in the first portion 603-1of the interior cavity 603 established through the first lumen 512 dfrom the second end 512 d-1 of the first lumen 512 d toward or to aproximal or first end of the first lumen 512 d may be accomplished orfacilitated or enabled in various manners. For example, FIG. 8B includessome sub-actions employed according to block 908 to establish therequired flow. In some particular embodiments, after the liquid 612 isprovided in the first portion 603-1 of the interior cavity 603 and afterthe seal is established according to block 906, the liquid 612 in atleast the first portion 603-1 of the interior cavity 603 is pressurizedto levels sufficient to facilitate or enable the establishing of therequired flow of liquid 612 through the first lumen 512 d from thesecond end 512 d-1 of the first lumen 512 d toward or to a proximal orfirst end of the first lumen 512 d. In this regard, at least in part,prevent fluid flow from the first lumen 512 d into the interior cavity603.

A valve 524 (FIGS. 5E, 5F), which is part of a coupling assembly 511 b,and which is fluidly coupled to the first lumen 512 d at a location atleast proximate the proximal end 512 a of elongate shaft member 500 b,may be positioned to occlude the first lumen 512 d during thepressurizing of the liquid 612 in the first portion 603-1 of theinterior cavity 603 of the vessel 602. Note that the coupling assembly511 b, described in more detail below, may be an alternate embodiment ofthe coupling assembly 511 a in FIG. 4A. According to some embodiments,once the liquid 612 in the first portion 603-1 of the interior cavity603 has reached a desired pressure (e.g., approximately 0.1 atmosphereaccording to some embodiments), valve 524 may be manipulated to notocclude the first lumen 512 d and thus allow for the required flow ofliquid 612 through the first lumen 512 d from the second end 512 d-1 ofthe first lumen 512 d toward or to a proximal or first end of the firstlumen 512 d. Unlike conventional proximal-to-distal flushing schemesthat provide a flushing liquid via a branched side port that restrictsthe liquid flow, the ability to selectively seal the vessel to anexterior surface of the distal end portion 512 e of the elongate shaftmember 500 b allows liquid 612 to flow directly into the second end 512d-1 of the first lumen and thus obtain flows that are not restricted andpotentially avoid the greater turbulence associated with conventionalbranched introductions of flushing liquid. In addition to the relativelyhigh flow rates provided by the direct entry (e.g., not via a branchedpath) of liquid 612 into the second end 512 d-1 of the first lumen,relatively large pressures may be imparted to the liquid 612 in interiorcavity 603 to provide even greater flow rates than those achievable withconventional techniques, thereby greatly enhancing the ability to flushan undesired fluid from the first lumen 512 d and reduce the number andsize of various bubbles of the undesired fluid that may cling to asurface of the first lumen 512 d.

Various methods may be employed to pressurize the liquid 612 in theinterior cavity 603 of vessel 602. For example, in some embodiments,various liquid pumps may be employed prior to, or during theestablishment of the flow of liquid 612 through the first lumen 512 d bypumping liquid 612 into the interior cavity 603 to achieve the necessarypressure(s). In some embodiments, the liquid in the interior cavity 603is pressurized after the liquid 612 is provided in the first portion603-1 of the interior cavity 603 (e.g., as per block 902). In someembodiments, the vessel 602 may include a wall portion (for instance, anoptional external wall portion 607 a shown, e.g., in broken line in FIG.5E or an optional internal wall portion 607 b shown, e.g., in brokenline in FIG. 5E), and method 900 may include moving at least part of thewall portion to exert an amount of pressure on the liquid 612 in thefirst portion 603-1 of the interior cavity 603, the amount of pressuresufficient to cause or at least facilitate or enable the establishing ofthe flow of at least some of the liquid 612 in the first portion 603-1of the interior cavity 603 through the first lumen 512 d from the secondend 512 d-1 of the first lumen 512 d toward the proximal or first end ofthe first lumen 512 d to flush the fluid other than the liquid 612 fromthe first lumen 512 d.

For example, the vessel 602 may include an exterior wall portion 607 athat contacts, is coupled to, or forms a wall of the vessel 602. Wallportion 607 a may exhibit a different degree of rigidity or flexibilitythan other walls of the vessel 602 according to various embodiments. Insome embodiments, wall portion 607 a may be more flexible or less rigidthan other walls of vessel 602. In some embodiments, wall portion 607 amay be less flexible or more rigid than other walls of vessel 602. Insome embodiments, wall portion 607 a forms a piston-like member slidablycoupled to vessel 602. In any case, mechanical force may be applied tothe exterior wall portion 607 a to cause at least part of it to move toexert pressure on the liquid 612 in the first portion 603-1 of theinterior cavity 603 when a quantity of the liquid is in the firstportion 603-1. For another example, the vessel 602 may include acompliant or semi-compliant interior wall portion 607 b (e.g., providedby a flexible membrane) between the first portion 603-1 of the interiorcavity 603 and a second portion 603-2 of the interior cavity 603. Thesecond portion 603-2 may be sized to contain at least a quantity ofparticular fluid other than the liquid 612 concurrently with the liquid612 received in the first portion 603-1 of the interior cavity 603. Amechanism (e.g., a piston-like member within the vessel 602) may beemployed to bear against the interior wall portion 607 b to cause atleast part of the internal wall portion 607 b to move toward the firstportion 603-1 and exert pressure on the liquid 612. Alternatively, or inaddition, a fluid may be provided into the second portion 603-2 asdescribed herein to cause at least part of the internal wall portion 607b to move toward the first portion 603-1 and exert pressure on theliquid 612 in the first portion 603-1 when a quantity of the fluid isreceived in the second portion 603-2. It is noted, however, that in someembodiments, liquid 612 is typically incompressible in nature and theinduced pressure may fall off rapidly once the flow of the liquid 612 isestablished though the first lumen 512 d. Accordingly, the pressureinduced on the liquid 612 may need to be repeatedly reestablished as theflow of the liquid proceeds or continues. In some embodiments, the wallportion 607 b may be provided by a moveable piston-like member withinthe vessel 602. In some embodiments, the wall portion 607 b may beprovided by a flexible membrane. Use of the internal wall portion 607 bmay be motivated by various reasons including segregating the particularfluid in the second portion 603-2 of the interior cavity from the liquid612 in the first portion 603-1 of the interior cavity (e.g., to preventintermixing or cross-contamination thereof).

FIG. 8C includes some sub-actions associated with block 910 of FIG. 8Bto pressurize the liquid 612 in the first portion 603-1 of the interiorcavity 603 of the vessel 602. Block 912 includes instructions to providea quantity of a particular fluid into a second portion of the interiorcavity 603 to pressurize the liquid 612 provided in the first portion603-1 of the interior cavity 603. In some embodiments, the particularfluid is the same as the liquid 612. For example, additional quantitiesof the liquid 612 may be pumped into the interior cavity 603 topressurize the liquid 612 in the first portion 603-1, for example, asdescribed above. In some embodiments, the particular fluid is differentthan the liquid. For example, the particular fluid may be a gas. In someembodiments, the particular fluid is a compressible fluid while theliquid 612 is an incompressible liquid. In various embodiments, thequantity of the particular fluid provided to the second portion 603-2according to block 912 is sufficient to exert an amount of pressure onthe liquid 612 in the first portion 603-1 of the interior cavity 603 tocause or at least facilitate or enable the establishing of the flow ofat least some of the liquid 612 in the first portion 603-1 of theinterior cavity 603 through the first lumen 512 d from the second ordistal end 512 d-1 of the first lumen 512 d toward the first or proximalend of the first lumen 512 d to flush undesired fluid (e.g., air)different than the liquid 612 at least from the first lumen 512 d. Itshould be noted that the actions of block 912 may be performed with orwithout either or both of the wall portions 607 a, 607 b. For example,the internal wall portion 607 b is not necessary in some embodimentswhere the particular fluid is added to the second portion 603-2, becausethe mere addition of the particular fluid to the second portion 603-2will act to increase pressure on the liquid 612 already present in thefirst portion 603-1.

It should also be noted that the volume and location thereof of thesecond portion 603-2 of the interior cavity 603 and the volume andlocation thereof of the first portion 603-1 of the interior cavity maybe transient in nature at least during the flushing of the first lumen512 d. In some embodiments where the particular fluid is a gas and theinternal wall portion 607 b does not exist, the volume of the secondportion 603-2 and the location thereof may be defined as the volume ofspace occupied by the gas within the interior cavity 603 of the vessel602, and the volume of the first portion 603-1 and the location thereofmay be defined as the volume of space occupied by the liquid 612 withinthe interior cavity 603 of the vessel 602, the volumes of space occupiedby the first and second portions 603-1, 603-2 varying at least duringthe flushing of the first lumen 512 d. Even in embodiments where theinternal wall portion 607 b is present, the volumes of space occupied bythe first and second portions 603-1, 603-2 may vary due to movements ofthe interior wall portion 607 b at least during the flushing of thefirst lumen 512 d.

FIG. 8D includes a method 900A for providing a quantity of particularfluid other than the liquid 612 into a second portion of the interiorcavity 603 while at least some of the liquid 612 is in the first portion603-1 of the interior cavity 603. In some embodiments, vessel 602includes a second port in fluid communication with the interior cavity603, the second port other than the first port 605 (i.e., the first port605 and the second port being different ports). In some embodiments,such second port is considered to not be part of the vessel 602. Block920 includes instructions to provide, via the second port, a quantity ofparticular fluid other than the liquid 612 into the second portion 603-2of the interior cavity 603 while at least some of the liquid 612 is inthe first portion 603-1 of the interior cavity 603. For example, FIG. 5Fshows the introduction of a particular fluid (e.g., air) other than theliquid 612 into the second portion 603-2 of the interior cavity 603, theparticular fluid introduced via a second port other than the first port605 in which the distal end portion 512 e of the elongate shaft member500 b is introducible. FIG. 5D shows a sectioned view of cap 604providing various ports including the first port 605, each of thevarious ports positionable in fluid communication with the interiorcavity 603 of the vessel at least in a state in which cap 604 is securedto vessel 602. In some embodiments (e.g., embodiments in which conduitmember 606 (i.e., described below) is not employed), port 614 providedby the cap 604 may be considered to be the second port in fluidcommunication with the interior cavity 603 of the vessel 602. In someembodiments (e.g., embodiments in which conduit member 606 (i.e.,described below) is not employed), port 615 provided by the cap 604 maybe considered to be the second port in fluid communication with theinterior cavity 603 of the vessel 602. It is noted that in someembodiments, the second port (e.g., 614, 615) may be in fluidcommunication with, or may be in contact with, the liquid 612 in thefirst portion 603-1 of the interior cavity 603. In this regard, theparticular fluid delivered to the second portion 603-2 of the interiorcavity 603 may travel through the liquid 612. For example, when theparticular fluid is a gas (e.g., air), a bubble stream of the gas mayflow through the liquid 612 from the second port (e.g., 614, 615) to thesecond portion 603-2 of the interior cavity 603. In some embodiments, atleast the first port 605, the second port (e.g., 614 or 615), or bothare provided in the cap 604.

In some embodiments, the vessel 602 or the flushing kit 600 includes aconduit member 606 arranged to fluidly communicate with a source 620 ofparticular fluid, and includes a first conduit end 606 a, a secondconduit end 606 b, and a second lumen 606-1 extending between the firstconduit end 606 a and the second conduit end 606 b. It may also bestated that the second lumen 606-1 extends from the first conduit end606 a to the second conduit end 606 b. In some embodiments, theabove-discussed second port is provided by the first conduit end 606 aor the second conduit end 606 b. In various embodiments, a flow of theparticular fluid is conveyed from the source 620 of the particular fluidthough the second lumen 606-1 of the conduit member 606 toward thesecond conduit end 606 b of the conduit member 606. In some embodiments,the first conduit end 606 a is arranged to receive the particular fluidfrom the source 620 of the particular fluid, and the second lumen 606-1is arranged to convey a flow of the particular fluid toward the secondconduit end 606 b. In various embodiments, the second conduit end 606 bis arranged to provide the particular fluid into the second portion603-2 of the interior cavity 603. For example, FIG. 5F shows that theconduit member 606 is arranged to locate the second conduit end 606 b inthe second portion 603-2 of the interior cavity 603 of the vessel 602.According to various embodiments, conduit member 606 is arranged tolocate the second conduit end 606 b at a location in the interior cavity603 away from the liquid 612 in the first portion 603-1 of the interiorcavity 603. In some embodiments, the second conduit end 606 b may bepositioned to avoid contact with liquid 612 in the first portion 603-1of the interior cavity 603.

In some embodiments, at least part (e.g., part 606 c shown in FIG. 5F)of the conduit member 606 is arranged to extend across at least part ofthe first portion 603-1 of the interior cavity 603 as shown in FIG. 5Fby way of non-limiting example. In some embodiments, the at least partof the conduit member 606 extending across the at least part of thefirst portion 603-1 of the interior cavity 603 contacts, or is wettedby, the liquid 612 in the first portion 603-1 of the interior cavity603. As can be visualized with respect to FIG. 5D, the second lumen606-1 of conduit member 606 is arranged to avoid receiving the distalend portion 512 e of the elongate shaft member 500 b when the distal endportion 512 e of the elongate shaft member 500 b is received in thefirst port 605. Stated another way, in some embodiments, the secondlumen 606-1 of conduit member 606 is arranged to prevent any receptionof the distal end portion 512 e of the elongate shaft member 500 b whenthe distal end portion 512 e of the elongate shaft member 500 b isinserted into the interior cavity 603 via the first port 605. That is,first port 605 and any of the ports provided by the first and secondconduit ends 606 a, 606 b are not collinearly arranged to concurrentlyallow the distal end portion 512 e to pass through all of these ports.In some embodiments, the second lumen 606-1 may be sized or include asize too small to allow the distal end portion 512 e of the elongateshaft member 500 b to pass through (e.g., as shown in FIG. 5D).

In view of the above, it should be noted that the above-discussed secondport may be provided by port 614, port 615, the first conduit end 606 a,or the second conduit end 606 b. In some embodiments, the second port isarrangeable to fluidly communicate with a particular fluid in the secondportion 603-2 of the interior cavity 603, the particular fluid otherthan the liquid 612. In some embodiments, the second port is arranged tofluidly communicate with a source 620 of the particular fluid other thanthe liquid 612 and provide the particular fluid into the second portion603-2 of the interior cavity 603 to pressurize the liquid 612 in thefirst portion 603-1. In some embodiments, the second port is arranged toprevent any reception of the distal end portion 512 e of the elongateshaft member 500 b when the distal end portion 512 e of the elongateshaft member 500 b is inserted into the interior cavity 603 via thefirst port 605. The second port may be arranged to avoid receiving thedistal end portion 512 e of the elongate shaft member 500 b when thedistal end portion 512 e of the elongate shaft member 500 b is receivedin the first port 605. That is, at least the second port may bepositioned to avoid receiving the distal end portion 512 e of theelongate shaft member 500 b when the distal end portion 512 e of theelongate shaft member 500 b is received in the first port 605, or thesecond port may have a size too small to receive the distal end portion512 e of the elongate shaft member 500 b. In some embodiments, thesecond port is positioned or is positionable to permit a flow of theparticular fluid through the second port while concurrently preventing aflow of the liquid 612 through the second port. This configuration mayexist at least during or in a state in which the particular fluid isprovided per block 920 or the liquid 612 is pressurized per block 912.For example, when the second port is provided by the second conduit end606 b, the second port may be positioned away from the liquid 612 in thefirst portion 603-1 of the interior cavity, thereby allowing a flow ofthe particular fluid through the second port while concurrentlypreventing a flow of the liquid 612 through the second port.

Referring back to FIG. 5F, source 620 of the particular fluid may beprovided at least in part by syringe 622 and may be employed accordingto blocks 912, 920 as per some example embodiments. In FIG. 5F, a firstvalve 624, a second valve 626, and a check valve 628 are operativelycoupled between source 620 of the particular fluid (e.g., syringe 622)and the second port (e.g., 606 a, 606 b, 614, or 615) to control a flowof the particular fluid from the source 620 to at least the second portin accordance with various embodiments. In some embodiments, the valves624, 626, and 628 are considered part of the source 620 and not part ofthe kit 600 shown in FIG. 5A. In various embodiments, the first valve624 is operatively coupled or arranged between port 614 or the firstconduit end 606 a and the source 620 (e.g., syringe 622). In variousembodiments, the second valve 626 is operatively coupled or arrangedbetween port 614 or the first conduit end 606 a and the source 620(e.g., syringe 622). In some embodiments, the second valve 626 isoperatively coupled or arranged between the check valve 628 and thesource 620 of the particular fluid. In various embodiments, the checkvalve 628 is operatively coupled or arranged between the source 620 ofthe particular fluid and the first valve 624.

According to some embodiments, each of the first valve 624 and thesecond valve 626 is selectively operable in a first state in which theparticular fluid is allowed to flow via the second port (or conduitmember 606 in applicable embodiments) from the source 620 (e.g., syringe622) of the particular fluid to the second portion 603-2 of the interiorcavity 603. In some embodiments, each of the first valve 624 and thesecond valve 626 is selectively operable in a second state in which theparticular fluid is restricted from flowing via the second port (orconduit member 606 in applicable embodiments) from the source 620 of theparticular fluid to the second portion 603-2 of the interior cavity 603.In some embodiments, at least the first valve 624 is selectivelyoperable in a third state in which the particular fluid is restrictedfrom flowing via the second port (or conduit member 606 in applicableembodiments) from the source 620 (e.g., syringe 622) of the particularfluid to the second portion 603-2 of the interior cavity 603, but isallowed to flow via the second port (or conduit member 606 in applicableembodiments) from the second portion 603-2 of the interior cavity 603 toa particular location located away from the source 620 of the particularfluid, the particular location not located in (a) the interior cavity603, (b) the elongate shaft member 500 b, or (a) and (b). For example,this functionality may be provided when the first valve 624 is athree-way valve. In some embodiments, the second valve 626 is a threeway valve. In some embodiments, both the first valve 624 and the secondvalve 626 are each provided by a respective three way valve.

According to some embodiments, the check valve 628 is operable torestrict at least a flow of the particular fluid from the first valve624 toward the source 620 (e.g., syringe 622) of a fluid such as theparticular fluid. In various embodiments, the check valve 628 isoperatively coupled between the first valve 624 and the second valve 626to allow a flow of the particular fluid in a direction from the secondvalve 626 toward the first valve 624, but to restrict a flow of theparticular fluid in a direction from the first valve 624 toward thesecond valve 626.

According to various embodiments, the particular fluid may be providedto the second portion 603-2 of the interior cavity 603 at least bymanipulating the first valve 624 to provide an unrestricted pathwaybetween the source 620 (e.g., syringe 622) of the particular fluid andthe second portion 603-2 of the interior cavity 603 (for example, thefirst state described above). If the particular fluid is present in tube622 a (at least FIG. 5F) of the syringe 622, the second valve 626 isalso manipulated to provide an unrestricted pathway between the source620 (e.g., syringe 622) of the particular fluid and the second portion603-2 of the interior cavity 603 (for example, the first state describedabove), and the plunger 622 b of the syringe 622 is pushed or advancedto cause the particular fluid to flow (e.g., via the second port orconduit member 606) into the second portion 603-2 of the interior cavity603. In some embodiments, the amount of particular fluid provided in thetube 622 a provides a desired amount of the particular fluid to thesecond portion 603-2 of the interior cavity 603. In other embodimentshowever, additional amounts of the particular fluid are required. Insome embodiments in which the second valve 626 is a three-way valve, thesecond valve 626 is operated in a state similar to the third statedescribed above with respect to first valve 624, the third stateassociated with the second valve 626 allowing for, or creating anotherflow path between the source 620 and another source of the particularfluid (e.g., the surrounding atmosphere) which allows a free additionalsupply of the particular fluid to be provided into the tube 622 a as theplunger 622 b is retracted. It is noted that the check valve 628prevents the particular fluid from being withdrawn from the secondportion 603-2 of the interior cavity 603 during the retraction of theplunger 622 b according to various embodiments.

According to various embodiments, once the syringe 622 has beenrecharged or resupplied with the particular fluid, the second valve 626is again operated to provide an unrestricted pathway between the source620 (e.g., syringe 622) of the particular fluid and the second portion603-2 of the interior cavity 603 (for example, the first state describedabove), and the plunger 622 b is advanced to provide the particularfluid to the second portion 603-2 of the interior cavity 603. Thisprocedure may be repeated until a desired quantity of the particularfluid has been delivered to the second portion 603-2 of the interiorcavity 603 of vessel 602, e.g., according to blocks 912 or 920.

According to various embodiments, the second portion 603-2 of theinterior cavity 603 is sized to receive at least a quantity ofparticular fluid sufficient to exert an amount of pressure on the liquid612 in the first portion 603-1 of the interior cavity 603, the amount ofpressure sufficient to cause movement of at least some of the liquid 612in the first portion of the interior cavity 603 into the second end 512d-1 of the first lumen 512 and flush the first lumen of the fluid otherthan the liquid 612 in the direction through the first lumen 512 dextending from the second end 512 d-1 of the first lumen 512 d towardthe first or proximal end of the first lumen 512 d. It is noted that thevalve 624 may be manipulated to prevent a flow of the liquid 612 thoughthe lumen 512 d when the quantity of the particular fluid is provided tothe second portion 603-2 of the interior cavity 603 to pressurize theliquid 612 in the first portion 603-1 of the interior cavity 603. Oncethe liquid 612 in the first portion 603-1 of the interior cavity 603 hasbeen adequately pressurized, valve 524 may be manipulated to allow forthe flow of the liquid 612 through the first lumen 512 d to flush afluid other than the liquid 612 that may reside in the first lumen 512d.

It is noted that relatively large pressures may be developed in theliquid stored in the first portion 603-1 of the interior cavity 603, andthat these relatively large pressures, when combined with the directentry of the liquid 612 into the distal end 512 d-1 of the first lumen,provide for enhanced flushing capabilities. It is further noted that,when the particular fluid is provided in the second portion 603-2 of theinterior cavity 603, the vessel 602 acts as a hydraulic accumulator orpressure storage reservoir in which the liquid 612 is held underpressure by the pressurized particular fluid (e.g., air). Theaccumulator enables the system to better respond to the flushing actionduring removal of any undesired fluids from the first lumen 512 d. Invarious embodiments, the accumulator may be employed to reduce or smoothout pulsations that may arise in a flow of the liquid 612.

After the flushing of the lumen 512 d has been completed, the elongateshaft member 500 b is removed from the vessel 602, for example, to allowfor a subsequent delivery of the elongate shaft member 500 b through abodily opening as described above. However, it is noted that anyremaining liquid 612 in the first portion 603-1 of the interior cavity603 may still be under pressure. If the elongate shaft member 500 b wasto be removed from the vessel 602 under this pressurized condition, atleast some of the liquid 612 in the first portion 603-1 of the interiorcavity 603 would likely erupt outwardly from the vessel 602 and possiblyspray a user (e.g., a health care practitioner) or various equipment.This is, understandably, an undesired outcome, especially when thevessel 602 acts a hydraulic accumulator that still may be storingrelatively high levels of energy. Accordingly, in some embodiments,liquid 612 in the first portion 603-1 of the interior cavity 603 isdepressurized prior to the removal of the elongate shaft member 500 bfrom vessel 602. In various embodiments, in which particular fluid otherthan the liquid 612 has been provided to second portion 603-2 of theinterior cavity 603 to pressurize the liquid 612, liquid 612 isdepressurized by removing the particular fluid from or otherwisedepressurizing the particular fluid in the second portion 603-2 of theinterior cavity 603. In some embodiments associated with FIG. 5F, thisremoval or otherwise depressurizing may be accomplished by manipulatingthe first valve 624 (e.g., a three-way valve) into a particular state(e.g., the third state associated with first valve 624 described above)to permit a flow (e.g., via the second port or the conduit member 606)of the particular fluid from the second portion 603-2 of the interiorcavity 603 to a location where the particular fluid can be released,drained, discharged, or dispersed. For example, when the particularfluid is air or some other gas, the first valve 624 may be manipulatedto divert the particular fluid to atmosphere and, thus, depressurize theparticular fluid in the second portion 603-2 and the liquid 612 in thefirst portion 603-1 of the interior cavity 603. It is noted thatdispersing a particular fluid, such as air, to the atmosphere or thesurrounding environment to reduce the pressure within the interiorcavity 603 of the vessel 602, instead of dispersing the liquid 612 toreduce the pressure, avoids the negative effects associated with aneruption of the liquid 612 as discussed above. In some embodiments,elongate shaft member 500 b may then be removed from the vessel 602 byfirst manipulating seal engaging member 610 to unseal the exteriorsurface of the distal end portion 512 e of the elongate shaft member 500b from the vessel 602. This unsealing may occur at least prior to adelivery of at least the distal end portion 512 e of the elongate shaftmember 500 b through a bodily opening leading to a bodily cavity.Separation or removal of the elongate shaft member 500 b from the vessel602 may occur at least prior to a delivery of at least the distal endportion 512 e of the elongate shaft member 500 b through a bodilyopening leading to a bodily cavity.

It is noted in various embodiments in which liquid 612 in the firstportion 603-1 of the interior cavity 603 is depressurized by thedepressurizing of the particular fluid in the second portion 603-2 ofthe interior cavity 603, it is advantageous to avoid contact between theliquid 612 and the depressurizing flow path of the particular fluidsince this would likely result in at least some of the liquid 612 beingsprayed into the atmosphere or the surrounding environment with theejected particular fluid. Accordingly, in some embodiments, the secondport is positioned to permit a flow of the particular fluid from thesecond portion 603-2 of the interior cavity 603 through the second portwhile concurrently preventing a flow of the liquid 612 from the firstportion 603-1 of the interior cavity 603 through the second port atleast during a state in which the liquid 612 in the first portion 603-1of the interior cavity 603 undergoes a reduction in pressure. Forexample, when the second port is provided by the second conduit end 606b of the conduit member 606, the second conduit end 606 b is positionedto avoid contact with liquid 612 in the first portion 603-1 of theinterior cavity 603, and thus allows for the removal of the particularfluid from the second portion 603-1 of the interior cavity 603 withoutremoval of at least some of the liquid 612. In some embodiments, atleast a portion of a wall member (e.g., interior wall portion 607 b)positioned between the first portion 603-1 of the interior cavity 603and the second portion 603-2 of the interior cavity 603 may be employedto separate the liquid 612 from the flow path that removes theparticular fluid from the second portion 603-2 of the interior cavity603.

In some embodiments, the vessel 602 is positionable to permit a flow ofthe particular fluid from the second portion 603-2 of the interiorcavity 603 through the second port while concurrently preventing a flowof the liquid 612 from the first portion 603-1 of the interior cavity603 through the second port at least during a state in which the liquid612 in the first portion 603-1 of the interior cavity 603 undergoes areduction in pressure. For example, in some embodiments in which conduitmember 606 is not employed, the second port may be provided by, forexample, a port located in cap 604 (e.g., second port 615). In someembodiments, the vessel 602 may be positioned such that the second port(e.g., 615) is submerged partially or fully in the liquid 612 at a timein which the particular fluid in the second portion 603-2 of theinterior cavity is to be depressurized. According to some embodiments,vessel 602 may be manipulated (e.g., tilted) to position a surface levelof the liquid 612 away from the second port (e.g., 615) to allow theparticular fluid to be removed via the second port from the secondportion 603-2 of the interior cavity without contacting the liquid 612.It is noted in various embodiments that the particular fluid is providedto, and removed from, the second portion 603-2 of the interior cavity603 via a same second port. In other embodiments, the particular fluidis provided to the second portion 603-2 of the interior cavity 603 viathe second port, and the particular fluid is removed from the secondportion 603-2 of the interior cavity 603 via a third port provided in orby the vessel 602, the third port other than the second port, and thethird port other than the first port 605 in which at least part of thedistal portion (e.g., 510 e, 512 e) of the elongate shaft member (e.g.,500 a, 500 b) is inserted. In various embodiments, the first port 605,the second port, and the third ports are different ports. In yet otherembodiments, the particular fluid is removed from the second portion603-2 of the interior cavity 603 via the second port, and the particularfluid is provided to the second portion 603-2 of the interior cavity 603via a third port provided in the vessel 602, the third port other thanthe second port and each of the second and third ports other than thefirst port 605. In various embodiments, the first port 605, the secondport, and the third ports are different ports. In some embodiments, thethird port is provided by the second port.

In some embodiments, after the first lumen 512 d has been flushed of afluid other than the liquid 612, a dilator may be introduced into thefirst lumen 512 d to provide a catheter sheath/dilator assembly that maybe subsequently delivered (e.g., percutaneously or intravascularly)through a bodily opening leading to a bodily cavity. For example, inFIG. 5G a dilator assembly 530 has been inserted into the first lumen512 d of the elongate shaft member 500 b of catheter sheath 512 from theproximal end 512 a of the elongate shaft member 500 b to the distal end512 b of the elongate shaft member 500 b. A tip portion 530 a of thedilator assembly 530 is shown protruding into the interior cavity 603 ofthe vessel 602.

Advantageously, any liquid 612 in the first lumen 512 d that may bepushed out of the first lumen 512 d by the inserted dilator assembly 530is supplanted or otherwise replaced by liquid 612 in the interior cavity603. It is noted that liquid 612 in the interior cavity 603 resistsexpulsion of liquid 612 in first lumen 512 d during the insertion of thedilator assembly 530 into the first lumen 512 d. Any undesired fluidthat is introduced into the first lumen 512 d during the insertion ofthe dilator assembly 530 into the first lumen 512 d may be flushed outof the first lumen 512 d via flushing techniques similar to or identicalto those taught above in this disclosure. It is noted that the dilatorassembly 530 may be removed at least partially from the first lumen 512d during subsequent flushing thereof.

According to some embodiments, before or after the elongate shaft member500 b is flushed according to the discussions above, various lumens inthe elongate shaft member 500 a may be flushed according to a same orsimilar procedure as that set forth above with respect to flushing ofthe elongate shaft member 500 b. In this regard, FIG. 6 illustrate,among other things, the flushing of various lumens of the elongate shaftmember 500 a of the catheter 510 as well as the removal of undesiredfluid from various other parts of the catheter 510, according to someembodiments. Procedures or structures not differentiated in FIG. 6 orthe accompanying descriptions below are the same or substantially thesame as those discussed above or illustrated with respect to figuresalready described.

As shown in FIG. 6A, the elongate shaft member 500 a may be insertedthrough a lumen of a loading assembly 528 to place a second part 510 e-1of the elongate shaft member 500 a, which comprises the distal end 510b, into the interior cavity 603 of the vessel 602. According to someembodiments, a proximal portion 528 a of the loading assembly 528 may beremovably or detachably coupled with a distal portion 528 b of theloading assembly 528 in a state where the cap 513 of the proximalportion 528 a is removed. According to various embodiments, a pathway isprovided between the physically coupled proximal portion 528 a of theloading assembly 528 and distal portion 528 b of the loading assembly528 b, the passageway extending between a first interior lumen of theproximal portion 528 a and a first interior lumen of the distal portion528 b. The distal portion 528 b of the loading assembly 528 may bethreadedly engaged to the vessel 602 by tightening of a threaded coupler702. In this regard, the loading assembly 528, (e.g., including thethreaded coupler 702) may correspond to the removable cap 604 discussedabove, and for at least this reason, may also form part of the vessel602. Accordingly, in some embodiments, an end of the first interiorlumen of the distal portion 528 b of the loading assembly 528 may beconsidered to correspond to the first port 605 discussed above.Alternatively, in some embodiments, an end of the interior lumen of theproximal portion 528 a of the loading assembly 528 may form a port 605 ashown in FIG. 6A, and port 605 a may be considered to correspond to thefirst port 605 discussed above.

The distal portion 528 b of the loading assembly 528 may include a port614 a that may correspond to the port 614 discussed above. Similarly,valves 626 a, 628 a, and 624 a may correspond to valves 626, 628, and624, discussed above, and may be coupled to the distal portion 528 b ofthe loading assembly 528 via tube 629 to provide fluid to or receivefluid from the port 614 a. Also, a port 615 a may correspond to port615, discussed above, and may fluidly communicate with the port 614 a.In this regard, the fluid communication channel or “second lumen”between ports 614 a and 615 a provided by the distal portion 528 b maybe distinct from either of the first lumen of the proximal portion 528 aof the loading assembly 528 or the first lumen of the distal portion 528b of the loading assembly 528 through which the distal end portion 510 eof the elongate shaft member 500 a is inserted, like the configurationof the cap 604 discussed above.

In some embodiments, a first part 510 e-2 of the distal end portion 510e may correspond to the first part 512 e-2 of the distal end portion 512e, discussed above. Accordingly, an exterior surface of the first part510 e-2 may be selectively sealed by a seal 608 a, which may correspondto the seal 608 discussed above. In this regard, the seal 608 a may bewithin a threaded coupling that, when turned, compresses the seal 608 aagainst the exterior surface of the first part 510 e-2 of the distal endportion 510 e of the elongate shaft member 500 a to seal the first part510 e-2 to a portion of the loading assembly 528. Also in this regard,the loading assembly 528 may be considered part of the vessel 602 insome embodiments, for example, in the configuration of at least FIG. 6A,where the loading assembly 528 is coupled to the vessel 602 via distalportion 528 b. In at least some of these embodiments, it may beconsidered that the seal 608 a selectively seals a cylindrical exteriorsurface of the first part 510 e-2 of the distal end portion 510 e to atleast part of the vessel 602.

With at least the configuration shown in FIG. 6A, liquid 612 in theinterior cavity 603 of the vessel 602 may be caused, according to theprocedures discussed above, to flow through the first lumen 510 d of theelongate shaft member 500 a from the second or distal end 510 d-1 of thefirst lumen 510 d toward or to the first or proximal end of the firstlumen 510 d (within the housing 520) to flush a fluid other than theliquid from the first lumen 510 d. In this regard, according to someembodiments, the liquid that proceeds into the housing 520 from thefirst or proximal end of the first lumen 510 d may proceed into aninterior chamber 708 of the housing 520 and then be released via a port,such as port 706.

In some embodiments, where a manipulable portion 502 is provided, themanipulable portion 502 may be delivered in its unexpanded configurationvia the first port (e.g., port 605 a) into the first portion 603-1 ofthe interior cavity 603. FIG. 6A illustrates a state according to someembodiments, where the manipulable portion 502 has been delivered intothe first portion 603-1 of the interior cavity 603.

The manipulable portion 502 itself may present a risk of trapping air orother undesired fluid. For example, the manipulable portion 502 mayinclude a plurality of elements or members (e.g., elongate members 304,504) that converge, overlap, or otherwise create regions capable ofentrapping air or other undesired fluid. Accordingly, the manipulableportion 502, in some embodiments, is moved into the expandedconfiguration, as shown in FIG. 6B, in the first portion 603-1 of theinterior cavity 603 to, for example, facilitate removal of any entrappedair or undesired fluid. In this regard, the manipulable portion 502 isselectively moveable from an unexpanded configuration, in which themanipulable portion 502 is sized for delivery through the first port(e.g., 605 a) and an expanded configuration in which the manipulableportion 502 is sized too large for delivery through the first port(e.g., 605 a). In some embodiments, the movement from the unexpandedconfiguration to the expanded configuration is facilitated by a slidingof the actuator 520 a from a first position shown in FIG. 6A to a secondposition shown in FIG. 6B. In some embodiments, when the manipulableportion 502 is in the expanded configuration in the first portion 603-1of the interior cavity 603, the manipulable portion 502 is repeatedlymoved, for example, by the hand movements shown in

FIG. 6B, to agitate the liquid 612 in the first portion 603-1 of theinterior cavity 603. In some embodiments, the manipulable portion 502may be repeatedly moved from the unexpanded or delivery configuration tothe expanded or deployed configuration and then back to the unexpandedor delivery configuration in the first portion 603-1 of the interiorcavity 603 while the manipulable portion 502 is wetted by the liquid 612in the first portion 603-1 of the interior cavity 603. In someembodiments, a volume of the first portion 603-1 is greater than avolume encompassed by the manipulable portion 502 when the manipulableportion is in the deployed or expanded configuration.

These repeated movements facilitate removal of trapped bubbles of air orother undesired fluid from the manipulable portion 502. It is noted thatseal 608 a is typically manipulated to not seal against the exteriorsurface of the first part 510 e-2 of the distal end portion 510 e of theelongate shaft member 500 a to permit the repeated movements of themanipulable portion 502 in the vessel 602. That is, the repeatedmovements of the manipulable portion 502 in the vessel 602 may requireunfettered movement of at least the elongate shaft member 500 a whichmay, in some embodiments, be provided when seal 608 a is not sealingagainst the exterior surface of the first part 510 e-2 of the distal endportion 510 e of the elongate shaft member 500 a. In situations in whichthe liquid in the first portion 603-1 of the interior cavity 603 is in apressurized state (e.g., pressurized to flush first lumen 510 d or stillpressurized after having flushed first lumen 510 d), the liquid may bedepressurized according to various methods similar or identical to thosediscussed above to avoid an undesired expulsion of the pressurizedliquid to the surrounding environment when the seal 608 a is manipulatedto not seal against the exterior surface of the first part 510 e-2 ofthe distal end portion 510 e of the elongate shaft member 500 a.

After the elongate shaft member 500 a has been flushed and trappedbubbles have been removed from the manipulable portion 502, themanipulable portion 502 may be moved into its unexpanded or deliveryconfiguration and retracted into a proximal region 528 a of the loadingassembly 528, which may then be sealed at the distal end of the proximalregion 528 a via cap 513. The proximal region 528 a of the loadingassembly 528 may be disconnected from the distal region 528 b, therebyallowing the proximal region 528 a of the loading assembly 528, with themanipulable portion 502 therein, to be transported for subsequentinsertion into a body (for example, via a coupling with a proximal endof elongate shaft member 500 b of catheter sheath 512).

While some of the embodiments disclosed above are suitable for cardiacmapping, the same or similar embodiments may be used for mapping otherbodily organs, for example gastric mapping, bladder mapping, arterialmapping and mapping of any bodily lumen, bodily chamber or bodily cavityinto which the devices of the present invention may be introduced.

While some of the embodiments disclosed above are suitable for cardiacablation, the same or similar embodiments may be used for ablating otherbodily organs or any bodily lumen, bodily chamber or bodily cavity intowhich the devices of the present invention may be introduced.

Subsets or combinations of various embodiments described above canprovide further embodiments.

These and other changes may be made to the invention in light of theabove-detailed description. In general, in the following claims, theterms used should not be construed to limit the invention to thespecific embodiments disclosed in the specification and the claims, butshould be construed to include other catheter systems including allmedical treatment catheter systems and medical diagnostic cathetersystems in accordance with the claims. Accordingly, the invention is notlimited by the disclosure, but instead its scope is to be determinedentirely by the following claims.

What is claimed is:
 1. A method of flushing a catheter, the cathetercomprising an elongate shaft member that includes a proximal end, adistal end, a length from the proximal end to the distal end, and atleast a first lumen extending between the proximal end and the distalend, wherein the first lumen comprises a first end spaced proximallyfrom a second end, the second end located at least proximate the distalend of the elongate shaft member, and wherein the distal end of theelongate shaft member is arranged to be deliverable ahead of theproximal end of the elongate shaft member through a bodily openingleading to a bodily cavity, the length of the elongate shaft membersufficient to position the proximal end outside a body comprising thebodily cavity during a state in which the distal end is positioned inthe bodily cavity, the catheter comprising a manipulable portionphysically coupled to a distal end portion of the elongate shaft member,and the method comprising: providing a vessel with the manipulableportion and at least part of the distal end portion of the elongateshaft member including the distal end of the elongate shaft member in aninterior cavity of the vessel, the manipulable portion and the at leastpart of the distal end portion of the elongate shaft member includingthe distal end of the elongate shaft member protruding into the interiorcavity of the vessel via a first port provided by the vessel, and themanipulable portion selectively moveable between an unexpandedconfiguration in which the manipulable portion is sized for deliverythrough the first port and an expanded configuration in which themanipulable portion is sized too large for delivery through the firstport; providing a quantity of a liquid into at least a first portion ofthe interior cavity of the vessel, the second end of the first lumen influid communication with the liquid provided in the first portion of theinterior cavity; establishing a flow of at least some of the liquid inthe first portion of the interior cavity through the first lumen fromthe second end of the first lumen toward the first end of the firstlumen to facilitate flushing of a fluid other than the liquid from thefirst lumen; repeatedly moving the manipulable portion, when themanipulable portion is in the expanded configuration in the firstportion of the interior cavity to agitate the liquid in the firstportion of the interior cavity and facilitate air bubble removal fromthe manipulable portion; and removing the manipulable portion, in theunexpanded configuration, and the at least part of the distal endportion of the elongate shaft member from the interior cavity of thevessel into a loading assembly for subsequent delivery through thebodily opening leading to the bodily cavity.
 2. The method of claim 1,wherein the vessel comprises a size too large for delivery of the vesselthrough the bodily opening leading to the bodily cavity at least in astate in which the first portion of the interior cavity is void of theliquid.
 3. The method of claim 1, wherein the liquid in at least thefirst portion of the interior cavity is pressurized.
 4. The method ofclaim 1, comprising pressurizing the liquid in at least the firstportion of the interior cavity after the liquid is provided in the firstportion of the interior cavity.
 5. The method of claim 1, comprisingpressurizing the liquid in at least the first portion of the interiorcavity to establish the flow of at least some of the liquid in the firstportion of the interior cavity through the first lumen from the secondend of the first lumen toward the first end of the first lumen tofacilitate flushing of the fluid other than the liquid from the firstlumen.
 6. The method of claim 1, comprising providing a particular fluidinto a second portion of the interior cavity to pressurize the liquidprovided in the first portion of the interior cavity.
 7. The method ofclaim 6, wherein the particular fluid is different than the liquid. 8.The method of claim 1, comprising providing a quantity of a particularfluid other than the liquid into a second portion of the interior cavitywhile at least some of the liquid is in the first portion of theinterior cavity.
 9. The method of claim 8, wherein the vessel comprisesa second port in fluid communication with the interior cavity, thesecond port other than the first port, and wherein at least some of thequantity of the particular fluid is provided into the second portion ofthe interior cavity at least through the second port.
 10. The method ofclaim 9, wherein the second port is arranged to prevent any reception ofthe distal end portion of the elongate shaft member when the distal endportion of the elongate shaft member is inserted into the interiorcavity via the first port .
 11. The method of claim 10, wherein thesecond port is positionable to permit a flow of the particular fluidthrough the second port while concurrently preventing a flow of theliquid through the second port.
 12. The method of claim 1, comprisingproviding a quantity of a particular fluid other than the liquid into asecond portion of the interior cavity, wherein the quantity of theparticular fluid is sufficient to exert pressure on the liquid in thefirst portion of the interior cavity, the pressure sufficient to causethe establishing the flow of the at least some of the liquid in thefirst portion of the interior cavity through the first lumen from thesecond end of the first lumen toward the first end of the first lumen tofacilitate flushing of the fluid other than the liquid from the firstlumen.
 13. The method of claim 12, comprising providing the quantity ofthe particular fluid other than the liquid into the second portion ofthe interior cavity after the quantity of the liquid has been providedinto at least the first portion of the interior cavity.
 14. The methodof claim 1, comprising providing a quantity of a particular fluid otherthan the liquid into a second portion of the interior cavity after thequantity of the liquid has been provided into at least the first portionof the interior cavity.
 15. The method of claim 9, wherein the vesselcomprises a wall portion, and the method comprises moving at least partof the wall portion to exert pressure on the liquid in the first portionof the interior cavity, the pressure sufficient to cause theestablishing the flow of the at least some of the liquid in the firstportion of the interior cavity through the first lumen from the secondend of the first lumen toward the first end of the first lumen tofacilitate flushing of the fluid other than the liquid from the firstlumen.
 16. The method of claim 15, wherein the wall portion is providedbetween the first portion of the interior cavity and the second portionof the interior cavity.
 17. The method of claim 8, wherein the vesselcomprises a conduit member comprising a first conduit end, a secondconduit end, and a second lumen extending between the first conduit endand the second conduit end, and the method comprises conveying a flow ofthe particular fluid though the second lumen toward the second conduitend, wherein the second conduit end is arranged to provide at least someof the quantity of the particular fluid into the second portion of theinterior cavity.
 18. The method of claim 17, wherein the conduit memberis arranged to locate the second conduit end at a location in theinterior cavity away from the liquid provided in the first portion ofthe interior cavity.
 19. The method of claim 18, wherein at least partof the conduit member extends across at least part of the first portionof the interior cavity.
 20. The method of claim 17, wherein the conduitmember is arranged to locate the second conduit end in the secondportion of the interior cavity.
 21. The method of claim 17, wherein thesecond lumen is arranged to prevent any reception of the distal endportion of the elongate shaft member when the distal end portion of theelongate shaft member is inserted into the interior cavity via the firstport.
 22. The method of claim 8, wherein the quantity of the particularfluid is sufficient to exert pressure on the liquid, and the pressuresufficient to cause the establishing the flow of the at least some ofthe liquid in the first portion of the interior cavity through the firstlumen from the second end of the first lumen toward the first end of thefirst lumen to facilitate flushing of the fluid other than the liquidfrom the first lumen.
 23. The method of claim 9, wherein the vesselcomprises a removable cap, the cap removable to provide access to theinterior cavity and wherein both the first port and the second port areprovided in the cap.
 24. The method of claim 1, wherein the vesselcomprises a removable cap, the cap removable to provide access to theinterior cavity and wherein the first port is provided in the cap. 25.The method of claim 1, comprising manipulating a seal member to seal anexterior surface of the distal end portion of the elongate shaft memberto at least part of the vessel, and subsequently, manipulating the sealmember to unseal the exterior surface of the distal end portion of theelongate shaft member from the at least part of the vessel at leastprior to a delivery of at least the distal end portion of the elongateshaft member through the bodily opening leading to the bodily cavity.26. The method of claim 25, comprising pressurizing the liquid in thefirst portion of the interior cavity after the manipulating the sealmember to seal the exterior surface of the distal end portion of theelongate shaft member to the at least part of the vessel but before themanipulating the seal member to unseal the exterior surface of thedistal end portion of the elongate shaft member from the at least partof the vessel.
 27. The method of claim 1, comprising moving themanipulable portion from the unexpanded configuration to the expandedconfiguration in the first portion of the interior cavity.
 28. Themethod of claim 1, comprising moving the manipulable portion from theunexpanded configuration to the expanded configuration while themanipulable portion is wetted by the liquid provided in the firstportion of the interior cavity.
 29. The method of claim 1, comprisingpressurizing the liquid in at least the first portion of the interiorcavity after the liquid is provided in the first portion of the interiorcavity to prevent fluid flow from the first lumen into the interiorcavity.
 30. The method of claim 6, wherein the providing the particularfluid into the second portion of the interior cavity to pressurize theliquid in the first portion of the interior cavity comprises providingthe particular fluid into the second portion of the interior cavity viaa second port provided by the vessel, and the method comprises removingat least some of the particular fluid from the second portion of theinterior cavity to depressurize the liquid in the first portion of theinterior cavity, the at least some of the particular fluid removed fromthe second portion of the interior cavity via a third port provided bythe vessel, each of the second port and the third port being other thanthe first port.
 31. The method of claim 30, wherein the third port isprovided by the second port.